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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.

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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.

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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.