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Regulatory Affairs Managers

SOC 11-9199.01Job Zone 4 · Considerable Preparationv.26.05

Context coveredThis framework covers regulatory affairs management practice across regulated product industries — including pharmaceuticals, medical devices, and consumer products — spanning submission preparation, agency interaction, compliance oversight, and strategic regulatory leadership.

Sources:O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.SkillsCrosswalkSkillsCrosswalk — O*NET enrichment + adjacency index. Opens in new tab.
Emerging
Entry / Apprentice
  1. Regulatory submission materials — review for completeness and formatting accuracy under direct supervision in a structured compliance environment.
  2. Applicable regulations and agency guidelines — identify and summarize to support team preparation of product dossiers.
  3. Product complaint records — compile and organize documentation following established protocols for regulatory reporting.
  4. Regulatory correspondence templates — draft initial responses to agency inquiries using approved language under senior guidance.
  5. Document management software — enter, track, and retrieve regulatory files within a centralized compliance system.
  6. Cross-functional team meetings — participate and record regulatory notes to support development project tracking.
  7. Regulatory submission timelines — monitor assigned milestones and flag potential delays to supervising managers.
  8. Basic scientific and legal terminology — apply in written summaries of product data reviewed for regulatory purposes.
  9. Compliance software tools — use to log and categorize regulatory requirements under direction from experienced staff.
  10. Internal regulatory procedures — follow consistently to maintain accuracy and auditability of submission packages.
Developing
Mid-level / Established
  1. Regulatory agency submissions — prepare and coordinate complete application packages for new products with limited oversight in a pharmaceutical, medical device, or consumer products environment.
  2. Product complaints and adverse event reports — investigate, document, and submit to appropriate regulatory authorities within required timeframes.
  3. Regulatory guidance documents — interpret and apply to routine design, development, and labeling questions raised by product teams.
  4. Agency inspection activities — assist in organizing and executing preparation processes, including document readiness reviews.
  5. Regulatory strategy drafts — develop for standard product submissions based on established precedent and current guidelines.
  6. Cross-departmental teams — coordinate regulatory input across R&D, quality, and marketing functions during product development cycles.
  7. Submission accuracy and compliance — review regulatory materials systematically using analytical and compliance software to identify gaps before filing.
  8. Written regulatory responses — compose clear, well-supported replies to agency inquiries regarding product safety or performance data.
  9. Regulatory databases and search tools — query to monitor evolving requirements and identify relevant precedents for ongoing projects.
  10. Time-sensitive submission schedules — manage independently, balancing multiple concurrent projects against agency-imposed deadlines.
Proficient
Senior / Expert IC
  1. Regulatory strategies and implementation plans — develop autonomously for new and complex products, integrating scientific, legal, and commercial considerations across domestic and international markets.
  2. Full regulatory agency submission packages — direct preparation and filing, ensuring timeliness, accuracy, and compliance with all applicable standards without supervisory review.
  3. Non-routine product complaints and regulatory violations — investigate thoroughly, determine reportability, and prepare detailed documentation for submission to competent authorities.
  4. Agency responses on product information and emerging issues — provide authoritative, technically sound replies that protect product approvals and company standing.
  5. Regulatory guidance to development teams — deliver proactively on design controls, clinical evidence requirements, and marketing claims throughout the product lifecycle.
  6. Audits and regulatory inspections — manage end-to-end, coordinating cross-functional responses and directing corrective action plans post-inspection.
  7. Product recall activities — lead regulatory notification, reporting, and documentation processes in coordination with quality and supply chain functions.
  8. Risk management and analytical software — apply to evaluate regulatory risk profiles and prioritize compliance investments across a product portfolio.
  9. Complex regulatory problems — resolve using systems analysis and inductive reasoning to anticipate agency positions and adapt submission strategies accordingly.
  10. Regulatory intelligence programs — establish and maintain to proactively identify legislative and guideline changes affecting current and pipeline products.
Advanced
Lead / Principal / Executive
  1. Enterprise-wide regulatory strategy — set and align with long-term business objectives, guiding senior leadership on risk, market access, and policy positioning across global jurisdictions.
  2. Organizational representation before major domestic and international regulatory agencies — lead on significant policy matters, product approvals, and enforcement proceedings that shape company standing.
  3. Regulatory affairs function — build, resource, and continuously improve to sustain organizational capability against evolving regulatory landscapes.
  4. Regulatory professionals and multidisciplinary teams — mentor, coach, and develop to elevate competency and succession readiness across the department.
  5. Policy advocacy positions — craft and advance before industry associations and regulatory bodies to shape favorable regulatory frameworks for the sector.
  6. High-stakes product recall and crisis response — direct regulatory communications strategy, executive briefings, and agency negotiations to protect public safety and company reputation.
  7. Cross-functional alignment on regulatory requirements — lead at the executive level, ensuring R&D, legal, commercial, and manufacturing strategies reflect current and anticipated compliance obligations.
  8. Regulatory submission governance standards — design and institutionalize to ensure consistency, quality, and defensibility of all filings across business units and geographies.
  9. Organizational risk posture — evaluate using systems-level judgment and executive decision-making frameworks to prioritize regulatory investments and pre-empt enforcement actions.
  10. Emerging regulatory technologies and data tools — champion adoption of advanced compliance, risk management, and document management platforms to drive efficiency and audit-readiness at scale.

AI-at-Work Competency Framework

Sources:Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab.Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab.WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab.
Subscriber feature

Authoritative source data identified for 998 occupations

How a worker at each mastery level uses, directs, and evaluates AI tools in this occupation. Each statement cites its evidence inline; click a citation chip to verify the source.

Emerging
  1. AI-drafted regulatory correspondence — uses AI tools to generate initial drafts of routine agency correspondence and cover letters, then reviews each output for accuracy and compliance with submission standards Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  2. Document formatting assistance — delegates structural formatting of regulatory submission packages to an AI assistant, while manually verifying all content against agency requirements Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
Developing
  1. Regulatory strategy research — directs AI tools to synthesize regulatory guidance documents, precedent decisions, and agency publications into structured summaries that inform submission planning, retaining full authorship of the resulting strategy Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
  2. Complaint documentation drafting — hands off factual complaint narratives to an AI assistant to produce initial draft documentation, then applies regulatory judgment to ensure accuracy, completeness, and appropriate regulatory tone before submission Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  3. Gap analysis acceleration — uses AI to cross-reference draft submission materials against applicable regulatory standards, identifying missing sections or inconsistencies that human review then adjudicates Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab. WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
Proficient
  1. End-to-end submission preparation — orchestrates AI assistance across multiple phases of a regulatory application—literature synthesis, section drafting, cross-reference checking—while retaining decision authority over scientific claims and risk representations Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
  2. Response-to-agency generation — directs an AI assistant to draft structured responses to regulatory agency information requests, then critically evaluates each claim against source data and company positions before submission Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  3. Regulatory timeline management — employs AI tools to model submission schedules, flag approaching deadlines, and surface dependency conflicts across concurrent product programs, with the manager making all prioritization decisions WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  4. Writing quality oversight — benchmarks AI-generated regulatory text against prior accepted submissions, applying reading comprehension and critical thinking to catch hedged language, unsupported claims, or scope drift that automated drafting introduces Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
Advanced
  1. AI workflow architecture for regulatory functions — designs and governs the organisation's AI-assisted regulatory submission workflow, specifying which task classes are delegated to AI, which require human sign-off, and how outputs are validated before agency filing Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab. WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  2. Strategic risk calibration — evaluates AI-generated regulatory strategy options against enterprise risk tolerance, competitive landscape, and agency relationship history, exercising judgment that AI tools cannot replicate given an autonomy index indicating moderate AI independence Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  3. Cross-functional AI governance — sets standards for AI tool use across regulatory, clinical, and quality teams, ensuring that AI-produced content entering any regulatory submission meets evidentiary and compliance thresholds WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  4. Continuous capability assessment — monitors measurable time-savings and task-completion patterns from AI tool deployment across the regulatory affairs function, using observed productivity data to justify resource reallocation and identify residual human-critical tasks Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  5. Novel submission strategy leadership — leads preparation of first-in-class or complex regulatory submissions where AI tools provide reference synthesis and draft scaffolding but the manager authors every strategic position, bridging Human-Technology Interaction competencies with deep regulatory expertise Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab. WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
Evidence pack
AEI usage
Task observations: 338
Augment share: 33.8%
Time saved: 83.6%
AI autonomy: 3.09
SAFI positioning
Top skill: Writing
Score: 51 / 100
Quadrant: Q2_ai_augmented
precision: exact
WEF cluster
Human-Technology Interaction
human_technology_interaction
Sources:Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab.WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab.Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab.

Pathsmith Durable Skills Framework

Sources:Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Subscriber feature

Ten durable-skill domains mapped to four proficiency/role levels for each occupation. Each statement is aligned to the Pathsmith taxonomy, derived from trusted grounding data and mapped to occupation-specific O*NET tasks and skills.

1Communication12 statements
Emerging
  1. Regulatory submission drafts — prepares basic sections of regulatory agency applications using standard templates and established formatting conventions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Agency correspondence — reads and interprets regulatory guidance documents to extract compliance requirements relevant to assigned product submissions O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Internal briefings — conveys preliminary regulatory requirements to cross-functional team members using plain language appropriate for non-regulatory audiences Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Submission narratives — writes comprehensive regulatory dossier sections that accurately represent scientific and clinical data in alignment with agency expectations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Agency response letters — drafts responses to regulatory agency information requests with accurate, well-organized product and safety information O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Regulatory guidance communication — translates complex agency requirements into actionable guidance for product development and marketing teams during project reviews Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory agency representation — presents company positions on product approval matters before domestic or international regulatory bodies with clarity, precision, and strategic framing Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Cross-departmental regulatory briefings — communicates regulatory strategy, timelines, and risk factors to senior leadership and project teams using audience-appropriate language and structured formats Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Complaint investigation reports — prepares thorough written documentation of product complaints and regulatory submissions that meet agency standards for completeness and accuracy O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Executive regulatory communication — leads enterprise-wide communication of regulatory policy changes, positioning implications, and strategic responses across business units and external stakeholders Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory narrative standards — establishes organizational writing standards and templates for regulatory submissions that improve consistency and agency acceptance rates Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Stakeholder alignment communication — facilitates high-stakes dialogues between company leadership, legal counsel, and regulatory bodies to resolve complex product approval disputes Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
2Leadership11 statements
Emerging
  1. Submission coordination — assists senior managers in coordinating the preparation of regulatory filings by tracking tasks and deadlines across contributing team members Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Team guidance — follows established regulatory procedures and communicates task expectations to junior staff or contractors during routine submission projects O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Regulatory project leadership — directs the preparation and submission of regulatory applications by assigning responsibilities, setting milestones, and ensuring quality standards are met Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Cross-functional team direction — guides product development and marketing teams through regulatory requirements during design and evaluation phases of new product programs O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Inspection readiness leadership — organizes and leads internal regulatory audit preparations, ensuring staff understand their roles and documentation is audit-ready Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory affairs department management — oversees regulatory staff performance, workload allocation, and professional development to maintain a high-functioning submissions team Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Strategic implementation leadership — develops and drives execution of regulatory strategies for multiple concurrent product submissions across product lines or therapeutic areas O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Recall and crisis management leadership — directs product recall activities, coordinating cross-functional teams and regulatory agency communications under time-sensitive conditions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Organizational regulatory vision — shapes the enterprise regulatory affairs function by defining long-term strategy, building capabilities, and aligning regulatory objectives with business growth plans Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory talent development — mentors regulatory affairs professionals at multiple career levels, building institutional knowledge and succession depth within the organization Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Industry leadership — represents the organization in industry working groups or regulatory advisory committees to influence policy development and shape regulatory standards O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
3Metacognition9 statements
Emerging
  1. Regulatory learning self-assessment — identifies personal gaps in knowledge of specific regulatory frameworks and seeks targeted training or mentorship to address them Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Submission error reflection — reviews rejected or questioned regulatory submissions to identify personal reasoning errors or documentation oversights for future improvement Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Regulatory strategy evaluation — monitors own decision-making process when developing submission strategies, checking assumptions against current agency guidance before finalizing approaches Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Knowledge currency monitoring — tracks own familiarity with evolving regulatory requirements and proactively updates understanding when guidance documents or standards change Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Strategic reasoning audit — evaluates the logic and assumptions embedded in regulatory strategies before presenting them to leadership or regulatory agencies to anticipate challenges and strengthen positions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Cognitive load management — recognizes when simultaneous high-priority submissions create cognitive overload and implements delegation or prioritization adjustments to maintain quality of judgment Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Learning transfer application — applies lessons from prior regulatory agency interactions to calibrate communication strategies and documentation approaches in subsequent submissions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Metacognitive modeling — coaches regulatory staff to examine their own regulatory reasoning, identify cognitive biases in risk assessments, and refine their analytical frameworks Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Institutional learning systems — establishes after-action review processes for major regulatory submissions and agency interactions to capture organizational learning and prevent recurring errors Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
4Critical Thinking11 statements
Emerging
  1. Regulatory text analysis — reads and interprets agency guidance documents to identify applicable requirements and distinguish mandatory provisions from recommendations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Compliance gap identification — compares draft submission materials against regulatory checklists to detect missing or inconsistent documentation before review O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Risk-benefit evaluation — analyzes product data to assess regulatory risk and identify whether evidence supports submission readiness under applicable agency standards Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory strategy assessment — evaluates multiple submission pathways for a new product, weighing regulatory risk, timeline, and evidence requirements to recommend the most viable approach O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Agency feedback analysis — interprets regulatory agency queries and deficiency letters to identify underlying concerns and formulate substantive, evidence-based responses Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Systems evaluation — assesses organizational regulatory processes to identify systemic weaknesses in submission quality, compliance documentation, or internal review workflows Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Complaint investigation reasoning — investigates product complaints by evaluating causal evidence, regulatory obligations, and submission requirements to determine appropriate agency reporting actions O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Policy interpretation — analyzes new or amended regulations to determine their operational implications for current product lines and development pipelines Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Enterprise regulatory risk reasoning — synthesizes competitive intelligence, regulatory agency trends, and internal pipeline data to form strategic judgments about regulatory risk exposure across the portfolio Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Complex problem resolution — leads resolution of novel regulatory problems involving ambiguous agency guidance, scientific uncertainty, or conflicting jurisdictional requirements across international markets Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Decision framework development — builds critical thinking frameworks and decision trees for regulatory classification, submission pathway selection, and risk escalation that standardize judgment across the department Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
5Collaboration10 statements
Emerging
  1. Cross-functional participation — contributes regulatory requirements and documentation needs to product development team meetings, supporting shared understanding of compliance obligations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Submission team coordination — works with scientific, clinical, and technical contributors to collect and organize data sections needed for regulatory filings O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Project team integration — partners with R&D, legal, quality, and marketing teams to align regulatory strategies with product development timelines and business objectives Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Audit team collaboration — works with quality assurance and operations teams to coordinate inspection readiness activities, document preparation, and corrective action responses O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. External agency collaboration — engages constructively with regulatory agency reviewers during pre-submission meetings to clarify requirements and resolve data questions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory guidance partnership — collaborates with design and development teams throughout the product lifecycle to integrate regulatory requirements early and avoid downstream compliance failures Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Multi-site submission coordination — leads collaboration across geographically distributed regulatory and technical teams to deliver synchronized submissions to multiple international agencies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Recall coordination — collaborates across regulatory, quality, supply chain, and communications functions to manage product recalls in compliance with agency-mandated timelines and reporting requirements O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Enterprise collaboration infrastructure — designs and implements cross-functional regulatory collaboration frameworks that connect regulatory affairs with legal, medical, commercial, and manufacturing stakeholders at the strategic planning level Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Industry consortium participation — represents the organization in collaborative industry-agency working groups to co-develop regulatory guidance and share best practices across the sector Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
6Character10 statements
Emerging
  1. Regulatory integrity — submits only accurate, verified information in regulatory documents and flags discrepancies or uncertainties to supervisors rather than omitting them Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Professional accountability — takes ownership of assigned submission tasks, communicates progress honestly, and discloses errors promptly so they can be corrected before agency submission Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Ethical compliance counsel — advises internal teams on regulatory obligations with impartiality, prioritizing legal compliance over commercial pressure when the two conflict Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Confidentiality stewardship — handles proprietary product data, competitive intelligence, and agency correspondence with strict adherence to confidentiality and data integrity standards Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Transparency in reporting — prepares adverse event and complaint reports to regulatory agencies with complete factual disclosure, even when findings reflect unfavorably on company products O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory ethics leadership — models ethical conduct in all agency interactions and internal advisory roles, holding team members accountable to truthful, complete regulatory representations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Conflict of interest management — identifies and discloses potential conflicts of interest in regulatory decisions, ensuring organizational credibility and agency trust are preserved Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Accountability in adverse outcomes — accepts institutional responsibility for submission errors or compliance failures, leads transparent post-incident reviews, and implements corrective actions without deflection Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Organizational integrity culture — establishes regulatory affairs department norms that institutionalize ethical submission practices, honest agency communication, and zero tolerance for data manipulation Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Industry ethics representation — advocates for ethical regulatory practices in industry forums, contributing to standards that protect public safety and maintain the integrity of regulatory systems Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
7Creativity9 statements
Emerging
  1. Submission problem-solving — proposes alternative documentation approaches when standard templates do not adequately represent novel product attributes or unique regulatory circumstances Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Regulatory research exploration — explores non-obvious agency guidance documents or precedent decisions to identify creative pathways for ambiguous product classification challenges Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Strategic pathway innovation — develops creative regulatory submission strategies that leverage expedited review designations, novel precedents, or adaptive approaches to accelerate product approval timelines Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Gap resolution creativity — designs novel approaches to address regulatory agency deficiencies when standard data or documentation formats do not satisfy reviewer concerns Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory strategy design — creates comprehensive, tailored regulatory development plans for innovative or combination products that navigate ambiguous regulatory frameworks across multiple jurisdictions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Process innovation — redesigns internal regulatory submission workflows to eliminate bottlenecks, reduce cycle times, and improve document quality through creative use of technology and process restructuring Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Novel argument construction — develops original scientific and regulatory arguments to support product classifications or label claims that lack direct agency precedent Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Regulatory innovation leadership — pioneers new organizational approaches to regulatory strategy, including adaptive submission frameworks and real-world evidence integration, that position the company ahead of evolving agency expectations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Cross-industry creative application — imports innovative regulatory strategies from adjacent industries or international regulatory systems to solve domestic submission challenges in novel ways Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
8Growth Mindset9 statements
Emerging
  1. Regulatory feedback acceptance — receives supervisor and agency feedback on submission drafts constructively and applies corrections without defensiveness to improve subsequent versions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Regulatory learning engagement — participates actively in training on new guidance documents, regulatory frameworks, and agency expectations to build foundational competence Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Agency rejection learning — analyzes complete response letters and regulatory refusals to extract lessons that strengthen future submission strategies and documentation practices Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Skill expansion in adjacent domains — pursues knowledge in related areas such as clinical trial design, manufacturing quality, or international regulatory requirements to broaden regulatory effectiveness Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory change adaptation — responds to new or amended agency regulations by proactively revising internal strategies, templates, and team guidance before compliance deadlines arise Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Performance stretch in complex submissions — voluntarily takes on regulatory challenges involving novel product types or unfamiliar jurisdictions to develop capabilities beyond current expertise Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Post-inspection improvement — treats regulatory agency inspection findings as development opportunities and leads systematic improvements to prevent recurrence and raise compliance standards Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Growth culture modeling — demonstrates continuous personal development through advanced regulatory certifications, peer publications, and public regulatory forum participation while encouraging the same from direct reports Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Organizational learning from failure — institutionalizes lessons-learned processes after regulatory setbacks, transforming individual and team mistakes into organizational capability improvements Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
9Mindfulness10 statements
Emerging
  1. Submission attention management — maintains focused attention during detailed review of regulatory documents to detect errors, inconsistencies, or missing required elements before submission Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Stress recognition — recognizes early signs of deadline-driven stress during high-volume submission periods and applies basic self-regulation techniques to maintain document review quality Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Deliberate review practice — approaches complex regulatory submissions with intentional, systematic review habits that prevent cognitive shortcuts and reduce risk of compliance errors Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Emotional regulation in agency interactions — manages personal reactions during adversarial agency negotiations or product rejection discussions to maintain professional composure and constructive dialogue Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Present-moment prioritization — focuses decision-making attention on the highest-impact regulatory risk in a crowded portfolio rather than defaulting to the loudest or most recent concern Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Intentional regulatory judgment — pauses to assess assumptions, evidence quality, and potential consequences before finalizing high-stakes regulatory positions or agency representations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Team emotional climate awareness — monitors team stress levels during intensive inspection or submission periods and adjusts workload, communication, and support to prevent quality degradation Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Mindful escalation decisions — applies deliberate, non-reactive judgment when determining whether product complaints or adverse events require regulatory agency reporting, avoiding both under- and over-reporting Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Organizational mindfulness practices — introduces structured reflection and deliberate decision-making protocols into regulatory affairs workflows to improve judgment quality under pressure across the department Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. High-stakes composure modeling — demonstrates and teaches calm, intentional regulatory leadership during product crises or agency enforcement actions, setting a standard of measured response for the entire team Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
10Fortitude9 statements
Emerging
  1. Deadline persistence — sustains effort and accuracy on regulatory filings under tight agency submission deadlines without compromising documentation completeness Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Rejection resilience — continues advancing regulatory strategies after initial agency rejections by treating deficiency letters as actionable guidance rather than final obstacles Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Sustained compliance effort — maintains rigorous regulatory compliance practices across extended product development cycles that span months or years before agency approval is achieved Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Uncertainty navigation — proceeds with regulatory planning and submission preparation under conditions of ambiguous agency guidance or evolving regulatory requirements without waiting for perfect clarity Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Crisis fortitude — leads regulatory response during product recalls, enforcement actions, or safety crises with sustained decisiveness and composure over extended high-pressure periods Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory adversity management — sustains organizational momentum through prolonged agency review delays, repeated information requests, or contested product classifications without abandoning strategic direction Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Courageous compliance counsel — delivers unwelcome regulatory opinions to senior business leaders when commercial pressures conflict with compliance requirements, maintaining position under organizational pushback Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Enterprise resilience leadership — builds organizational resilience by preparing the regulatory affairs function to withstand major adverse regulatory events, including enforcement actions or market withdrawals, without loss of strategic capability Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Perseverance through systemic barriers — leads multi-year regulatory campaigns for innovative or controversial products, sustaining team commitment and strategic coherence through repeated setbacks and shifting agency landscapes Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Sources:Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
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Related titles
CMC Director (Chemistry, Manufacturing, and Controls Director) · CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager) · Compliance Director · Global RA Director (Global Regulatory Affairs Director) · Global RA Manager (Global Regulatory Affairs Manager) · International Regulatory Affairs Specialist · RA and Compliance Director (Regulatory Affairs and Compliance Director) · RA Director (Regulatory Affairs Director) · RA Manager (Regulatory Affairs Manager) · RA QA Director (Regulatory Affairs Quality Assurance Director) · RA VP (Regulatory Affairs Vice President) · Regulatory Affairs Executive
RAPIDS apprenticeships
—
O*NET skills
WritingReading ComprehensionActive ListeningSpeakingCritical ThinkingSystems EvaluationComplex Problem SolvingJudgment and Decision MakingSystems AnalysisTime ManagementMonitoringActive LearningCoordinationSocial PerceptivenessInstructingPersuasionNegotiationManagement of Personnel ResourcesLearning Strategies
Knowledge domains
English LanguageLaw and GovernmentAdministration and ManagementBiologyEducation and TrainingAdministrativeChemistry
Abilities
Written ExpressionOral ComprehensionOral ExpressionWritten ComprehensionInductive ReasoningDeductive ReasoningSpeech ClarityProblem SensitivityNear VisionSpeech Recognition
Work styles
Attention to DetailDependabilityIntegrityCautiousnessLeadership OrientationIntellectual Curiosity
Technology
Document management softwareAnalytical or scientific softwareCompliance softwareData base user interface and query softwareInformation retrieval or search softwareDesktop publishing softwareElectronic mail softwareDevelopment environment softwareRisk management data and analysis softwareSpreadsheet software
Tasks · seed anchors for statements
  1. Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  2. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  3. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  4. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  5. Provide responses to regulatory agencies regarding product information or issues.
  6. Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  7. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  8. Manage activities such as audits, regulatory agency inspections, or product recalls.
CIP education codes
09.070211.100525.010125.010330.060130.120230.390130.400130.420130.450130.460130.470130.510130.520130.520230.520339.080142.010142.270142.270242.270342.270442.270542.270642.270742.270842.270942.271042.279942.280142.280242.280342.280442.280542.280642.280742.280842.280942.281042.281142.281242.281342.281442.289942.999943.010043.010343.011543.020243.030143.030243.030343.030443.040444.040144.040244.049945.010145.010245.010345.019945.020145.020245.020345.020445.020545.029945.030145.040145.050145.050245.059945.060145.060245.060345.060445.060545.069945.070145.070245.079945.090145.090245.099945.100145.100245.100345.100445.109945.110145.110245.110345.119945.120145.130145.150145.999950.100150.100250.100450.109951.071951.200952.010152.020152.020652.021052.021152.021352.021452.021652.070152.070252.070352.070452.090352.099952.210154.010154.010254.010354.010454.010554.010654.010754.010854.0199

Sources: O*NET v30.2 (CC BY 4.0), SkillsCrosswalk.com, LER.me, Anthropic Economic Index, SAFI (Jadhav & Danve, 2026), WEF Skills Taxonomy 2021, Pathsmith Durable Skills Framework. © 2026 EBSCOed.