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.

A 4-level framework describing how a worker at each mastery level uses, directs, and evaluates AI tools in this occupation. Each statement cites its evidence inline. Subscribe for $19.99/mo to read the full framework — or sign in if you have a subscription.

  1. Emerging
  2. Developing
  3. Proficient
  4. Advanced
Monthly subscription · Stripe-hosted · unlocks AI-at-Work and Pathsmith™ Durable Skills across the full library

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 levels for this occupation. Subscribe to unlock the full Pathsmith™ Durable Skills Framework across all 1,016 occupations.

Monthly subscription · Stripe-hosted · unlocks AI-at-Work and Pathsmith™ Durable Skills across the full library
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.