Occupation · SOC 11-9199.01
Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Median wage
$136,550
$68,860–$227,590
Projected growth
+4.5%
Average growth
Annual openings
5,980
per year
Employed (US)
630,980
Job Zone 4
Typical preparation
Considerable preparation
Stackable credential programs
8,371 mapped
Core skills
WritingReading ComprehensionSpeakingActive ListeningCritical ThinkingSystems EvaluationSystems AnalysisJudgment and Decision MakingComplex Problem SolvingTime ManagementMonitoringCoordinationActive LearningSocial PerceptivenessInstructingPersuasionNegotiationManagement of Personnel ResourcesLearning StrategiesService OrientationOperations AnalysisScienceMathematicsManagement of Financial ResourcesManagement of Material ResourcesProgrammingOperations MonitoringTechnology DesignQuality Control AnalysisTroubleshootingRepairingOperation and ControlInstallationEquipment SelectionEquipment Maintenance
Knowledge areas
English LanguageLaw and GovernmentAdministration and ManagementBiologyEducation and TrainingChemistryAdministrativeComputers and ElectronicsMedicine and DentistryMathematicsProduction and ProcessingEngineering and TechnologyDesignPersonnel and Human ResourcesPublic Safety and SecurityCustomer and Personal ServicePhysicsCommunications and MediaSales and MarketingMechanicalForeign LanguagePsychologyEconomics and AccountingTelecommunicationsSociology and AnthropologyBuilding and ConstructionGeographyTherapy and CounselingTransportationFood ProductionPhilosophy and TheologyHistory and ArcheologyFine Arts
Technology & tools
Adlib ExpressAdobe AcrobatAnalyse-itAris Global RegisterAxway eSubmissionsDatabase softwareDatafarm S-CubedDatafarm a-PulseDatafarm eCTDGatekeeperDatafarm eCTDViewerDialog DialogLinkDocument publishing softwareDoubleBridge ROSETTA Phoenix eCTD ViewerDoubleBridge ROSETTA PyramidDoubleBridge ROSETTA SceptreDoubleBridge ROSETTA ScribeElectronic common technical document eCTD softwareElectronic common technical document eCTD validating softwareElectronic common technical document eCTD viewing softwareElectronic document management system EDMSEnterprise content management ECM softwareExtedo DOCvalidatorExtedo PLmanagerExtedo eCTDmanager SuiteGlobalSubmit REVIEWGlobalSubmit VALIDATEIBM NotesImage Solutions ISIPublisherImage Solutions eCTDXpressIntegrated development environment IDE softwareLorenz DocuBridgeLorenz eValidatorLorenz labelBridgeMasterControl softwareMedXView eCTDauditorMediRegs E-dition Compliance MonitorMediRegs Pharmaceutical Regulation SuiteMediRegs Regulation and Reimbursement SuiteMediRegs Risk Assessment ManagerMicrosoft Access
Representative tasks
Evaluating Information to Determine Compliance with StandardsCommunicating with People Outside the OrganizationInterpreting the Meaning of Information for OthersCommunicating with Supervisors, Peers, or SubordinatesGetting InformationMaking Decisions and Solving ProblemsUpdating and Using Relevant KnowledgeWorking with ComputersDocumenting/Recording InformationProcessing InformationIdentifying Objects, Actions, and EventsAnalyzing Data or InformationEstablishing and Maintaining Interpersonal RelationshipsDeveloping Objectives and StrategiesOrganizing, Planning, and Prioritizing WorkProviding Consultation and Advice to OthersTraining and Teaching OthersThinking CreativelyResolving Conflicts and Negotiating with OthersCoaching and Developing OthersDeveloping and Building TeamsGuiding, Directing, and Motivating SubordinatesCoordinating the Work and Activities of OthersScheduling Work and ActivitiesMonitoring Processes, Materials, or SurroundingsJudging the Qualities of Objects, Services, or PeopleSelling or Influencing OthersPerforming Administrative ActivitiesEstimating the Quantifiable Characteristics of Products, Events, or InformationStaffing Organizational UnitsMonitoring and Controlling ResourcesInspecting Equipment, Structures, or MaterialsAssisting and Caring for OthersPerforming for or Working Directly with the PublicPerforming General Physical ActivitiesDrafting, Laying Out, and Specifying Technical Devices, Parts, and EquipmentControlling Machines and ProcessesHandling and Moving ObjectsRepairing and Maintaining Electronic EquipmentOperating Vehicles, Mechanized Devices, or Equipment
Competency framework
Skill expectations by proficiency level.
emerging
Regulatory submission materials — review for completeness and formatting accuracy under direct supervision in a structured compliance environment.Applicable regulations and agency guidelines — identify and summarize to support team preparation of product dossiers.Product complaint records — compile and organize documentation following established protocols for regulatory reporting.Regulatory correspondence templates — draft initial responses to agency inquiries using approved language under senior guidance.Document management software — enter, track, and retrieve regulatory files within a centralized compliance system.Cross-functional team meetings — participate and record regulatory notes to support development project tracking.Regulatory submission timelines — monitor assigned milestones and flag potential delays to supervising managers.Basic scientific and legal terminology — apply in written summaries of product data reviewed for regulatory purposes.Compliance software tools — use to log and categorize regulatory requirements under direction from experienced staff.Internal regulatory procedures — follow consistently to maintain accuracy and auditability of submission packages.
developing
Regulatory agency submissions — prepare and coordinate complete application packages for new products with limited oversight in a pharmaceutical, medical device, or consumer products environment.Product complaints and adverse event reports — investigate, document, and submit to appropriate regulatory authorities within required timeframes.Regulatory guidance documents — interpret and apply to routine design, development, and labeling questions raised by product teams.Agency inspection activities — assist in organizing and executing preparation processes, including document readiness reviews.Regulatory strategy drafts — develop for standard product submissions based on established precedent and current guidelines.Cross-departmental teams — coordinate regulatory input across R&D, quality, and marketing functions during product development cycles.Submission accuracy and compliance — review regulatory materials systematically using analytical and compliance software to identify gaps before filing.Written regulatory responses — compose clear, well-supported replies to agency inquiries regarding product safety or performance data.Regulatory databases and search tools — query to monitor evolving requirements and identify relevant precedents for ongoing projects.Time-sensitive submission schedules — manage independently, balancing multiple concurrent projects against agency-imposed deadlines.
proficient
Regulatory strategies and implementation plans — develop autonomously for new and complex products, integrating scientific, legal, and commercial considerations across domestic and international markets.Full regulatory agency submission packages — direct preparation and filing, ensuring timeliness, accuracy, and compliance with all applicable standards without supervisory review.Non-routine product complaints and regulatory violations — investigate thoroughly, determine reportability, and prepare detailed documentation for submission to competent authorities.Agency responses on product information and emerging issues — provide authoritative, technically sound replies that protect product approvals and company standing.Regulatory guidance to development teams — deliver proactively on design controls, clinical evidence requirements, and marketing claims throughout the product lifecycle.Audits and regulatory inspections — manage end-to-end, coordinating cross-functional responses and directing corrective action plans post-inspection.Product recall activities — lead regulatory notification, reporting, and documentation processes in coordination with quality and supply chain functions.Risk management and analytical software — apply to evaluate regulatory risk profiles and prioritize compliance investments across a product portfolio.Complex regulatory problems — resolve using systems analysis and inductive reasoning to anticipate agency positions and adapt submission strategies accordingly.Regulatory intelligence programs — establish and maintain to proactively identify legislative and guideline changes affecting current and pipeline products.
advanced
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.Organizational representation before major domestic and international regulatory agencies — lead on significant policy matters, product approvals, and enforcement proceedings that shape company standing.Regulatory affairs function — build, resource, and continuously improve to sustain organizational capability against evolving regulatory landscapes.Regulatory professionals and multidisciplinary teams — mentor, coach, and develop to elevate competency and succession readiness across the department.Policy advocacy positions — craft and advance before industry associations and regulatory bodies to shape favorable regulatory frameworks for the sector.High-stakes product recall and crisis response — direct regulatory communications strategy, executive briefings, and agency negotiations to protect public safety and company reputation.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.Regulatory submission governance standards — design and institutionalize to ensure consistency, quality, and defensibility of all filings across business units and geographies.Organizational risk posture — evaluate using systems-level judgment and executive decision-making frameworks to prioritize regulatory investments and pre-empt enforcement actions.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.
Also known as
22 alternate job titles map to this occupation.
CMC Director (Chemistry, Manufacturing, and Controls Director)CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager)Compliance DirectorGlobal RA Director (Global Regulatory Affairs Director)Global RA Manager (Global Regulatory Affairs Manager)International Regulatory Affairs SpecialistRA 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 ExecutiveRegulatory Affairs Project Manager (Regulatory Affairs PM)Regulatory DirectorRegulatory ManagerRegulatory Operations Manager (Regulatory Ops Manager)Regulatory Oversight ManagerRegulatory Process ManagerRegulatory Program ManagerRegulatory Reporting ManagerRegulatory Reports ManagerVaccine RA Director (Vaccine Regulatory Affairs Director)