NSXNational Skills ExchangeSign in
Back to Framework

Regulatory Affairs Specialists

SOC 13-1041.07Job Zone 4 · Considerable Preparationv.26.05

Context coveredThis framework covers regulatory affairs practice in pharmaceutical, medical device, and related industry sectors, spanning domestic and international submission management, agency engagement, compliance analysis, and organizational regulatory leadership calibrated to Job Zone 4 preparation.

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 document packages — assemble and organize under direct supervision in a pharmaceutical or medical device regulatory affairs setting.
  2. Regulatory submission templates — complete standard sections by following established protocols and internal checklists.
  3. Technical files and product dossiers — gather supporting materials as directed to aid in preparation and maintenance of approval documentation.
  4. Regulatory agency correspondence — draft routine cover letters and responses using pre-approved language under senior specialist guidance.
  5. Regulatory rules and updates — review published rule changes and summarize key findings for team review in a supervised workflow.
  6. Document management software — enter, retrieve, and organize regulatory records within established database systems on a daily basis.
  7. Submission requirement checklists — identify applicable domestic regulatory pathways for straightforward product types with supervisor input.
  8. Internal policies and procedures — apply current regulatory guidance by following written SOPs across routine compliance tasks.
  9. Recall or market withdrawal documentation — compile preliminary data and draft initial reports under direct oversight during withdrawal events.
  10. Regulatory databases and information retrieval tools — conduct structured searches to support background research on compliance requirements.
Developing
Mid-level / Established
  1. Regulatory submissions for domestic projects — coordinate preparation and review with moderate oversight, ensuring completeness before filing deadlines.
  2. Pre-submission strategy meetings — participate in communications with regulatory agencies to clarify requirements and refine submission plans.
  3. Technical files and approval documentation — maintain and update product files independently to sustain ongoing market authorizations.
  4. Agency-requested information packages — prepare detailed responses to regulatory queries, synthesizing data from cross-functional teams.
  5. Regulatory rule changes — interpret updates to applicable regulations and draft revised internal procedures for department review.
  6. Labeling change submissions — determine the appropriate submission type required for proposed changes and initiate the corresponding regulatory action.
  7. Document management and analytical software — apply tools proficiently to track submission status and analyze compliance data across active projects.
  8. Cross-functional project teams — coordinate regulatory timelines and deliverables with R&D, quality, and legal colleagues on mid-complexity product programs.
  9. Recall coordination activities — manage documentation and agency notifications for market withdrawals following established recall procedures.
  10. Regulatory risk assessments — evaluate standard device or product modifications to identify compliance implications with limited supervisory input.
Proficient
Senior / Expert IC
  1. Domestic and international regulatory submissions — lead end-to-end preparation, review, and filing across multiple simultaneous complex product programs.
  2. Regulatory agency relationships — conduct pre-submission meetings and ongoing correspondence autonomously to negotiate pathways and resolve open issues.
  3. Non-routine agency inquiries — prepare and deliver comprehensive technical responses independently, drawing on deep knowledge of applicable regulations and product science.
  4. Regulatory pathway strategy — determine the optimal submission strategy for novel devices or products by applying inductive and deductive reasoning to ambiguous regulatory frameworks.
  5. Corporate regulatory policy — interpret new or revised rules and translate them into updated policies, procedures, and training materials distributed across the organization.
  6. Technical files for complex products — oversee maintenance and gap analysis of multi-market approval documentation to sustain regulatory status across jurisdictions.
  7. Recall and market withdrawal operations — direct all regulatory facets of withdrawal events, including agency notifications, field communications, and effectiveness checks.
  8. Systems-level compliance analysis — evaluate interrelated regulatory, quality, and commercial systems to identify risk exposure and recommend corrective actions.
  9. Submission type determinations — independently adjudicate which regulatory filings are required for proposed product, process, or labeling changes in high-stakes situations.
  10. Regulatory intelligence programs — monitor evolving guidance documents, draft standards, and enforcement trends to proactively inform product development and lifecycle decisions.
Advanced
Lead / Principal / Executive
  1. Enterprise regulatory strategy — set the organization's global submission and compliance roadmap, aligning regulatory investments with business objectives at the executive level.
  2. Regulatory agency engagement at senior levels — lead high-stakes negotiations and policy dialogues with agency leadership to shape favorable regulatory pathways for the product portfolio.
  3. Cross-functional regulatory governance — establish and chair regulatory review boards that integrate input from R&D, legal, medical affairs, and commercial teams across the enterprise.
  4. Organizational regulatory capability — design and implement competency development programs that build regulatory affairs expertise across specialist and management ranks.
  5. Global regulatory submission infrastructure — architect standardized processes, templates, and document management systems that scale across domestic and international markets.
  6. Regulatory risk governance — develop enterprise-wide risk frameworks for evaluating product changes, market expansions, and post-market commitments at the portfolio level.
  7. Recall and crisis response leadership — lead organizational response to major market withdrawals, directing cross-functional teams and serving as primary executive liaison to regulatory authorities.
  8. Policy and industry influence — represent the organization in trade associations and public comment processes to influence emerging regulations affecting the industry sector.
  9. Regulatory affairs performance metrics — define KPIs, monitor submission cycle times, and drive continuous improvement initiatives that measurably accelerate time-to-approval.
  10. Emerging technology regulatory positioning — guide the organization's regulatory approach to novel technologies, setting precedent strategies that address first-in-class evidentiary and classification challenges.

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-assisted document drafting — uses an LLM to generate first drafts of routine regulatory correspondence and cover letters, then reviews each output for accuracy against internal standards Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  2. Regulatory template population — feeds standard form fields and product data into an AI tool to pre-fill submission templates, reducing manual entry time on well-defined sections Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
Developing
  1. Submission gap analysis — directs an AI assistant to cross-reference a draft regulatory dossier against agency guidance documents, flagging missing sections or inconsistent terminology before human review 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. Regulatory pathway summarization — prompts an LLM to synthesize applicable domestic and international regulatory pathways from dense guidance texts, then applies judgment to select the appropriate route for a specific product 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..
  3. Agency correspondence drafting — tasks an AI tool with producing structured responses to agency information-request letters, retaining personal authorship of all strategic positions and factual commitments Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
Proficient
  1. Multi-jurisdictional submission coordination — orchestrates an AI workflow that compiles, reformats, and quality-checks regulatory packages for parallel domestic and international filings, while personally validating every regulatory claim 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. Technical file maintenance — delegates routine document version-control tracking and cross-reference updates within technical files to an AI assistant, then audits output for completeness and regulatory accuracy Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  3. Regulatory intelligence monitoring — configures an LLM pipeline to continuously summarize new guidance documents, Federal Register notices, and agency communications, then interprets implications for active product portfolios WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  4. Compliance test requirement mapping — instructs an AI tool to extract and tabulate applicable compliance test requirements from regulatory standards, then exercises expert judgment to confirm scope and identify omissions Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
Advanced
  1. Pre-submission strategy formulation — leads the design of AI-augmented analytical workflows that model regulatory risk across multiple product classifications and jurisdictions, synthesizing AI-generated data analysis with regulatory precedent to advise senior stakeholders 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. AI output governance for regulatory submissions — establishes team-level protocols defining which submission components may incorporate AI-generated content, what human review gates apply, and how AI limitations are disclosed to regulatory agencies, ensuring institutional accountability Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
  3. Complex inquiry response architecture — directs AI tools to aggregate and structure technical evidence packages in response to major agency deficiency letters, then authors all substantive scientific and regulatory arguments, maintaining full professional accountability for the final submission Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  4. Regulatory process optimization — evaluates time-savings data and AI autonomy patterns across the submissions function to identify where AI collaboration adds demonstrable efficiency, and redesigns team workflows accordingly Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  5. Cross-functional AI capability mentorship — coaches junior regulatory affairs staff on effective AI prompting strategies, critical evaluation of LLM outputs for regulatory accuracy, and the professional boundaries of AI delegation in a compliance context 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: 231
Augment share: 23.1%
Time saved: 85.6%
AI autonomy: 2.69
SAFI positioning
Top skill: Active Listening
Score: 42.2 / 100
Quadrant: Q2_ai_augmented
precision: exact
WEF cluster
Data Science and Analysis
data_science_and_analysis
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.

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.

1Communication10 statements
Emerging
  1. Regulatory document drafts — writes initial sections of submission cover letters and summaries under supervisor guidance using standard regulatory templates 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 basics — composes routine follow-up emails to regulatory agencies using established templates and approved language O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Pre-submission strategy memos — articulates proposed regulatory pathways in written briefing documents for internal stakeholders with increasing clarity and precision 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 regulatory updates — presents compliance rule changes verbally to product development and quality teams using accessible, non-technical language 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. Agency clarification responses — prepares detailed written responses to regulatory agency questions during active submission review, accurately addressing each query within required timelines O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Corporate policy communication — interprets regulatory rule changes and translates them into updated corporate procedures distributed across departments O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Regulatory submission narratives — authors complete technical summaries, clinical overviews, and labeling text for domestic and international submissions with precision and compliance 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. Executive regulatory briefings — communicates complex regulatory risk assessments and strategic pathway recommendations to C-suite and board-level audiences with authority and clarity Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Agency relationship communication — leads high-stakes dialogue with FDA, EMA, or equivalent agencies during pre-submission meetings, negotiating positions and resolving ambiguities on behalf of the organization O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Regulatory communication standards — develops organizational templates, style guides, and communication protocols that improve submission quality across the regulatory affairs team Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
2Leadership10 statements
Emerging
  1. Submission task ownership — takes responsibility for assigned regulatory document sections and meets deadlines without requiring repeated follow-up Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Team meeting participation — volunteers relevant regulatory research findings during team discussions to support submission preparation efforts Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Regulatory project coordination — coordinates preparation timelines and document compilation across internal contributors for a single regulatory submission O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Junior staff guidance — provides feedback and direction to regulatory coordinators or associates on document formatting and agency requirement compliance Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Submission team leadership — leads cross-functional teams through the full lifecycle of a regulatory submission, assigning tasks, resolving bottlenecks, and ensuring on-time delivery O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Recall coordination leadership — directs recall or market withdrawal activities by coordinating regulatory, quality, and commercial teams under time-sensitive conditions O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Regulatory strategy initiative — proactively identifies regulatory risks in product development pipelines and proposes mitigation strategies without waiting for direction Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Regulatory affairs function leadership — builds and mentors a high-performing regulatory affairs team, establishing workflows, competency standards, and professional development pathways Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Organizational regulatory vision — shapes the enterprise-wide regulatory strategy across multiple product lines and geographies, aligning regulatory goals with 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.
  3. Industry leadership — represents the organization on regulatory industry working groups or advisory panels, influencing emerging regulatory guidance and standards Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
3Metacognition8 statements
Emerging
  1. Regulatory knowledge gaps — identifies personal unfamiliarity with specific submission types or agency requirements and seeks targeted learning resources Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Submission error reflection — reviews returned or queried submissions to identify personal process gaps and adjusts preparation approach accordingly Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Learning strategy selection — chooses appropriate methods such as agency guidance documents, peer review, or training courses to build competency in unfamiliar regulatory domains Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Decision-making awareness — recognizes when a regulatory determination exceeds current knowledge and escalates to senior colleagues or external experts before proceeding 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 reasoning evaluation — monitors own interpretation of ambiguous regulatory requirements during submission preparation, cross-checks reasoning against precedent and guidance, and documents rationale 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. Workflow self-assessment — periodically evaluates personal submission preparation processes for inefficiencies and implements improvements that reduce error rates and cycle times Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Expertise boundary modeling — transparently models metacognitive practices for junior team members by articulating uncertainty, checking assumptions aloud, and demonstrating iterative reasoning during complex regulatory reviews Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Strategic self-regulation — monitors cognitive load during high-volume submission cycles and applies deliberate workload management strategies to maintain decision quality under pressure Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
4Critical Thinking9 statements
Emerging
  1. Submission type identification — applies basic decision criteria to determine which regulatory submission category applies to a proposed product change using agency guidance documents O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory text comprehension — reads and identifies key requirements within agency regulations, guidance documents, and Federal Register notices relevant to assigned products O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Regulatory pathway analysis — evaluates multiple potential regulatory pathways for a product and assesses relative risks, timelines, and evidentiary requirements of each option 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. Labeling change assessment — analyzes proposed labeling modifications against current approvals and regulatory requirements to determine required submission type and supporting data O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Compliance gap analysis — systematically compares existing product technical files or submissions against current regulatory standards to identify deficiencies and required corrective actions O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Agency response evaluation — critically assesses regulatory agency information requests during review, distinguishing factual queries from substantive scientific or regulatory concerns that require strategic response 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. International regulatory comparison — evaluates differences in domestic and international regulatory requirements to develop jurisdiction-specific submission strategies O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Regulatory risk adjudication — leads organization-wide assessment of complex regulatory scenarios with ambiguous requirements, synthesizing legal, scientific, and precedent-based evidence to reach defensible 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. Emerging regulation anticipation — analyzes proposed rulemaking, agency signals, and industry trends to identify future compliance requirements and builds them into product development plans before finalization 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.
5Collaboration9 statements
Emerging
  1. Cross-functional document gathering — collects technical, clinical, and quality data from subject-matter experts across departments to support assigned submission sections O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Team norm adherence — follows established regulatory team workflows, version control conventions, and review schedules to contribute reliably to shared submission projects Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. R&D and regulatory alignment — works with product development engineers or scientists to identify regulatory implications of design decisions early in the development cycle O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Quality system coordination — collaborates with quality assurance teams to ensure regulatory submissions accurately reflect validated manufacturing processes and quality data O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Global submission teamwork — coordinates preparation and review activities across geographically dispersed regulatory, clinical, and commercial teams for multinational submissions O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Agency meeting preparation — facilitates cross-functional rehearsals and briefing document reviews with scientific, legal, and executive stakeholders prior to regulatory agency interactions 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 team integration — partners with quality, supply chain, legal, and communications teams during market withdrawal events to align regulatory reporting with operational response O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Regulatory-commercial integration — bridges regulatory and commercial functions by embedding regulatory strategy into product launch planning, lifecycle management, and business development decisions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. External partner regulatory collaboration — leads joint regulatory strategy development with contract research organizations, licensing partners, or co-development collaborators, managing shared accountability for submission outcomes 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.
6Character9 statements
Emerging
  1. Regulatory data integrity — accurately records and reports data in submission documents without falsification or omission, even when findings are unfavorable to the product Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Deadline accountability — acknowledges submission timeline commitments and communicates proactively when risks to on-time delivery are identified Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Conflict of interest recognition — identifies situations where commercial pressure may influence regulatory recommendations and raises concerns through appropriate channels Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Confidential information stewardship — handles proprietary product data, agency correspondence, and competitive intelligence with discretion and in compliance with confidentiality obligations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Regulatory ethics application — maintains submission accuracy and completeness even when facing organizational pressure to accelerate timelines or minimize unfavorable data 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 — accepts responsibility for errors in submitted regulatory documents, initiates corrective communications with agencies, and implements process improvements to prevent recurrence Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Transparent agency relations — communicates honestly with regulatory agencies about product limitations, testing anomalies, and manufacturing deviations without misrepresentation O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Organizational ethics culture — establishes and champions regulatory integrity standards within the organization, creating systems that make ethical submission practices the default rather than the exception Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Whistleblower courage — identifies and escalates systemic regulatory compliance failures within the organization, accepting personal and professional risk to protect public safety and organizational integrity Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
7Creativity8 statements
Emerging
  1. Alternative data sourcing — identifies non-traditional data sources such as published literature or registry data to support regulatory arguments when proprietary data is limited Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Submission format adaptation — proposes minor formatting or organizational improvements to standard submission templates to improve reviewer comprehension Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Novel pathway exploration — researches and proposes emerging regulatory mechanisms such as Breakthrough Device Designation or Accelerated Approval when standard pathways present disproportionate barriers O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory argument construction — develops creative but defensible scientific and regulatory arguments to address agency concerns that lack clear 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.
Applying
  1. Regulatory strategy innovation — designs non-obvious submission sequencing or phased approval strategies that reduce time-to-market while maintaining compliance across product families 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. Labeling differentiation — crafts product labeling that satisfies regulatory requirements while simultaneously creating clear, compelling communication that serves patient and clinician needs O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Regulatory model development — creates new internal frameworks, decision trees, or regulatory intelligence systems that enable the organization to navigate novel product categories or first-in-class technologies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Cross-industry regulatory adaptation — draws on regulatory precedents from adjacent industries or international markets to construct innovative submission strategies for products without established guidance 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 Mindset8 statements
Emerging
  1. Agency feedback integration — treats regulatory agency deficiency letters or information requests as learning opportunities and applies insights to improve subsequent submission quality Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Regulatory landscape curiosity — proactively reads new agency guidance documents, Federal Register notices, and industry publications to expand regulatory knowledge beyond current assignments Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Submission setback recovery — responds to rejected or delayed submissions by diagnosing root causes, revising strategy, and resubmitting with improved documentation rather than repeating prior approach 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. New domain acquisition — pursues competency in unfamiliar regulatory frameworks such as combination products, software as a medical device, or international submissions when organizational needs require it Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Regulatory change adaptation — adjusts submission strategies and internal procedures within short timeframes when agencies issue new guidance or change review standards for relevant product categories 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. Stretch assignment acceptance — volunteers for high-complexity submissions or unfamiliar product types to accelerate professional development and expand organizational regulatory capability Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Team learning culture — creates structured mechanisms such as post-submission debriefs, knowledge-sharing sessions, and regulatory intelligence digests that embed continuous learning into team operations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Regulatory paradigm adoption — leads organizational adaptation to major regulatory shifts such as new EU MDR requirements or FDA digital health frameworks, transforming uncertainty into competitive advantage 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.
9Mindfulness8 statements
Emerging
  1. Submission deadline awareness — maintains conscious awareness of concurrent submission deadlines and flags conflicts before they become critical rather than reacting at the last moment Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Review attention management — applies focused reading strategies when reviewing dense regulatory guidance documents to ensure accurate comprehension of requirements 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. Stress response regulation — recognizes signs of cognitive overload during high-volume submission periods and applies deliberate pacing or prioritization strategies to maintain accuracy Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Stakeholder emotion awareness — detects frustration or urgency in cross-functional partners during submission preparation and adjusts communication approach to maintain productive collaboration Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. High-stakes meeting presence — enters regulatory agency meetings with full situational awareness, actively tracking verbal and non-verbal agency signals and adjusting responses in real time 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. Intentional decision pacing — resists pressure to render rapid regulatory judgments on ambiguous submissions, deliberately pausing to gather evidence and consult precedent before committing to a position 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. Team emotional climate stewardship — monitors team stress levels during crisis events such as recalls or audit responses and intervenes with resource reallocation, communication support, or direct coaching to sustain performance Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Organizational attentiveness — maintains broad awareness of enterprise-wide product pipeline changes, business developments, and external regulatory signals that may affect submission strategy, integrating this awareness into proactive planning Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
10Fortitude8 statements
Emerging
  1. Submission pressure tolerance — maintains submission quality and accuracy when facing tight deadlines or repeated revision requests from internal reviewers Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Ambiguity endurance — continues regulatory research and analysis when clear guidance does not exist, working through uncertainty without abandoning the task Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Agency rejection persistence — sustains effort and strategic thinking following a complete response letter or submission rejection, rebuilding the regulatory package and reengaging the agency without discouragement 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 advocacy under pressure — maintains position on regulatory requirements when challenged by commercial or executive stakeholders who prefer faster or less rigorous approaches Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Recall response endurance — sustains regulatory coordination activities across extended market withdrawal events involving multiple agencies, complex logistics, and sustained organizational stress O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Long-cycle submission resilience — maintains motivation and submission quality across multi-year regulatory processes for complex products, adapting to evolving requirements without losing strategic coherence 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 crisis leadership — leads the organization through major compliance crises such as warning letters, consent decrees, or mandatory recalls, sustaining team morale and regulatory strategy integrity under extreme and prolonged adversity 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. Systemic opposition navigation — persists in pursuing necessary regulatory changes or honest agency communications despite sustained internal political resistance, protecting organizational and public safety interests over an extended period Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. 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.
Show O*NET source anchors59 anchors · skillscrosswalk.com

O*NET enrichment · skillscrosswalk.com

Suggest an O*NET correction

Source anchors that ground each statement

Related titles
Anti Money Laundering Compliance Analyst (AML Compliance Analyst) · Clinical Quality Assurance Associate · Clinical Quality Assurance Specialist · CMC Regulatory Affairs Manager (Chemistry, Manufacturing, and Controls Regulatory Affairs Manager) · Drug Regulatory Affairs Specialist · Product Safety Specialist · Product Stewardship Specialist · Quality Assurance Documentation Coordinator · Quality Assurance Documentation Specialist · Regulatory Affairs Analyst (RA Analyst) · Regulatory Affairs Associate (RA Associate) · Regulatory Affairs Consultant (RA Consultant)
RAPIDS apprenticeships
—
O*NET skills
Active ListeningWritingSpeakingJudgment and Decision MakingCritical ThinkingReading ComprehensionComplex Problem SolvingSystems AnalysisTime ManagementSocial PerceptivenessSystems EvaluationActive LearningMonitoringNegotiationCoordinationLearning StrategiesPersuasionInstructingService Orientation
Knowledge domains
English LanguageLaw and GovernmentBiologyComputers and ElectronicsAdministration and ManagementAdministrative
Abilities
Written ComprehensionWritten ExpressionOral ExpressionOral ComprehensionInductive ReasoningProblem SensitivityDeductive ReasoningSpeech ClaritySpeech RecognitionNear Vision
Work styles
Attention to DetailDependabilityCautiousnessIntegrityIntellectual CuriosityAchievement Orientation
Technology
Document management softwareAnalytical or scientific softwareData base reporting softwareData base user interface and query softwareAccounting softwareMedical softwareHuman resources softwareDevelopment environment softwareInformation retrieval or search softwareTransaction security and virus protection software
Tasks · seed anchors for statements
  1. Coordinate efforts associated with the preparation of regulatory documents or submissions.
  2. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  3. Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  4. Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  5. Prepare or maintain technical files as necessary to obtain and sustain product approval.
  6. Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  7. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  8. Coordinate recall or market withdrawal activities as necessary.
CIP education codes
03.010303.010403.020803.020930.410143.012151.071751.072051.221352.100152.1002

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.