Regulatory Affairs Managers
Medium47.41%
Salary Range
Low (10th %)$67,370
Median$133,560
High (90th %)$225,120
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Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
The automation risk for the occupation "Regulatory Affairs Managers" is estimated at 47.4%, which closely aligns with its base risk of 48.1%. This moderate risk reflects the profession’s mix of routine, automatable duties and more complex, judgment-driven responsibilities. The core tasks that are most susceptible to automation primarily involve process management and document handling. For instance, developing regulatory strategies and implementation plans, reviewing all regulatory agency submission materials for compliance, and directing the preparation and submission of applications, reports, or correspondence can increasingly be streamlined by advanced software. Such processes are procedural, rule-based, and can benefit from efficiency improvements afforded by automation technologies. Conversely, several vital tasks within this occupation remain highly resistant to automation due to their requirement for specialized judgment and adaptability. Evaluating new software publishing systems and conferring with regulatory agencies about updates are complex processes demanding both technical knowledge and interpersonal skills. Additionally, regulatory affairs managers are increasingly expected to assess "green" regulatory concerns—like toxic substance use or carbon footprint analyses—which require up-to-date expertise in evolving environmental policies. Monitoring emerging regulatory trends, particularly those related to environmental issues, requires the ability to synthesize new information, anticipate industry shifts, and provide strategic guidance, all of which are less amenable to automation. A key bottleneck skill for Regulatory Affairs Managers is originality, reflected in the low automation probabilities of 3.0% and 3.1% for tasks involving creative and novel solutions. Originality encompasses the ability to approach complex regulatory hurdles with innovative thinking, tailor strategies to unique company needs, and proactively address unforeseen compliance challenges. These skills are difficult to encode in algorithms because they involve subjective judgment, creativity, and nuanced understanding of both business and regulatory environments. As a result, while certain aspects of the occupation are readily automated, the need for original thought and complex problem-solving will continue to anchor a significant human role in regulatory affairs management.
Filter by Automatable Status
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Partially Automatable
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Partially Automatable
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
Partially Automatable
Provide responses to regulatory agencies regarding product information or issues.
Partially Automatable
Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Partially Automatable
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Partially Automatable
Maintain current knowledge of relevant regulations, including proposed and final rules.
Partially Automatable
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Partially Automatable
Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
Partially Automatable
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
Partially Automatable
Participate in the development or implementation of clinical trial protocols.
Partially Automatable
Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
Partially Automatable
Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
Partially Automatable
Establish regulatory priorities or budgets and allocate resources and workloads.
Partially Automatable
Train staff in regulatory policies or procedures.
Partially Automatable
Contribute to the development or implementation of business unit strategic and operating plans.
Partially Automatable
Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
Partially Automatable
Coordinate internal discoveries and depositions with legal department staff.
Partially Automatable
Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
Partially Automatable
Monitor regulatory affairs trends related to environmental issues.
Partially Automatable
Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
Partially Automatable
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
Partially Automatable
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Partially Automatable
Manage activities such as audits, regulatory agency inspections, or product recalls.
Partially Automatable
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
Partially Automatable
Develop and maintain standard operating procedures or local working practices.
Partially Automatable
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Partially Automatable
Reading ComprehensionActive ListeningComplex Problem SolvingOperations MonitoringQuality Control AnalysisSystems EvaluationManagement of Personnel ResourcesWritingSpeakingMathematicsScienceCritical ThinkingActive LearningLearning StrategiesMonitoringSocial PerceptivenessCoordinationPersuasionNegotiationInstructingService OrientationOperations AnalysisTechnology DesignEquipment SelectionInstallationProgrammingOperation and ControlEquipment MaintenanceTroubleshootingRepairingJudgment and Decision MakingSystems AnalysisTime ManagementManagement of Financial ResourcesManagement of Material Resources
Arm-Hand SteadinessAuditory AttentionCategory FlexibilityControl PrecisionDeductive ReasoningDepth PerceptionDynamic FlexibilityDynamic StrengthExplosive StrengthExtent FlexibilityFar VisionFinger DexterityFlexibility of ClosureFluency of IdeasGlare SensitivityGross Body CoordinationGross Body EquilibriumHearing SensitivityInductive ReasoningInformation OrderingManual DexterityMathematical ReasoningMemorizationMultilimb CoordinationNear VisionNight VisionNumber FacilityOral ComprehensionOral ExpressionOriginalityPerceptual SpeedPeripheral VisionProblem SensitivityRate ControlReaction TimeResponse OrientationSelective AttentionSound LocalizationSpatial OrientationSpeech ClaritySpeech RecognitionSpeed of ClosureSpeed of Limb MovementStaminaStatic StrengthTime SharingTrunk StrengthVisual Color DiscriminationVisualizationWrist-Finger SpeedWritten ComprehensionWritten Expression
BiologyPsychologySociology and AnthropologyGeographyEngineering and TechnologyAdministration and ManagementAdministrativeEconomics and AccountingSales and MarketingCustomer and Personal ServicePersonnel and Human ResourcesProduction and ProcessingComputers and ElectronicsDesignBuilding and ConstructionMechanicalMathematicsPhysicsForeign LanguageHistory and ArcheologyMedicine and DentistryFine ArtsPhilosophy and TheologyLaw and GovernmentTelecommunicationsCommunications and MediaTransportationEnglish LanguageEducation and TrainingTherapy and CounselingPublic Safety and SecurityFood ProductionChemistry
Getting InformationMonitoring Processes, Materials, or SurroundingsIdentifying Objects, Actions, and EventsInspecting Equipment, Structures, or MaterialsEstimating the Quantifiable Characteristics of Products, Events, or InformationJudging the Qualities of Objects, Services, or PeopleProcessing InformationEvaluating Information to Determine Compliance with StandardsAnalyzing Data or InformationMaking Decisions and Solving ProblemsThinking CreativelyUpdating and Using Relevant KnowledgePerforming General Physical ActivitiesHandling and Moving ObjectsControlling Machines and ProcessesOperating Vehicles, Mechanized Devices, or EquipmentWorking with ComputersRepairing and Maintaining Electronic EquipmentDocumenting/Recording InformationDrafting, Laying Out, and Specifying Technical Devices, Parts, and EquipmentInterpreting the Meaning of Information for OthersCommunicating with Supervisors, Peers, or SubordinatesCommunicating with People Outside the OrganizationEstablishing and Maintaining Interpersonal RelationshipsOrganizing, Planning, and Prioritizing WorkAssisting and Caring for OthersSelling or Influencing OthersRepairing and Maintaining Mechanical EquipmentResolving Conflicts and Negotiating with OthersPerforming for or Working Directly with the PublicCoordinating the Work and Activities of OthersDeveloping and Building TeamsTraining and Teaching OthersGuiding, Directing, and Motivating SubordinatesCoaching and Developing OthersProviding Consultation and Advice to OthersPerforming Administrative ActivitiesStaffing Organizational UnitsMonitoring and Controlling ResourcesDeveloping Objectives and StrategiesScheduling Work and Activities
Adlib ExpressAnalyse-itAris Global RegisterMicrosoft OutlookMicrosoft ProjectMicrosoft SharePointSAP softwareWeb browser softwareTableauDatabase softwareIBM NotesMicrosoft AccessMicrosoft WindowsWord processing softwareStatistical analysis softwareMicrosoft ExcelSpreadsheet softwareDatafarm a-PulseDatafarm eCTDGatekeeperDatafarm eCTDViewerDialog DialogLinkDoubleBridge ROSETTA Phoenix eCTD ViewerDoubleBridge ROSETTA PyramidDoubleBridge ROSETTA ScribeElectronic common technical document eCTD validating softwareElectronic document management system EDMSEnterprise content management ECM softwareExtedo DOCvalidatorExtedo eCTDmanager SuiteExtedo PLmanagerGlobalSubmit REVIEWImage Solutions eCTDXpressImage Solutions ISIPublisherLorenz eValidatorLorenz labelBridgeMediRegs Pharmaceutical Regulation SuiteMediRegs Risk Assessment ManagerMedXView eCTDauditorOctagon StartingPointOctagon ViewPoint eCTD CompleteRisk management softwareSamarind RMSSAP EHS ManagementThomson Reuters Liquent CoreDossier Submission Accelerator for eCTDThomson Reuters Liquent InSight SuiteTotal quality management TQM softwareVirtify eCTDMicrosoft VisioMicrosoft ExcelMicrosoft OutlookMicrosoft ProjectMicrosoft SharePointSAP softwareTableauDatabase softwareIBM NotesMicrosoft AccessMicrosoft VisioMicrosoft WindowsStatistical analysis softwareMasterControl softwareAdlib ExpressAnalyse-itDatafarm a-PulseDatafarm eCTDViewerDialog DialogLinkDoubleBridge ROSETTA Phoenix eCTD ViewerDoubleBridge ROSETTA ScribeElectronic document management system EDMSEnterprise content management ECM softwareExtedo DOCvalidatorExtedo eCTDmanager SuiteExtedo PLmanagerImage Solutions eCTDXpressLorenz eValidatorLorenz labelBridgeMediRegs Pharmaceutical Regulation SuiteMediRegs Risk Assessment ManagerMedXView eCTDauditorOctagon StartingPointRisk management softwareSamarind RMSThomson Reuters Liquent CoreDossier Submission Accelerator for eCTDThomson Reuters Liquent InSight SuiteVirtify eCTDAxway eSubmissionsDatafarm S-CubedDoubleBridge ROSETTA SceptreGlobalSubmit VALIDATESoftware development toolsLorenz DocuBridgePilgrim Regulatory SubmissionXML authoring softwareWord processing softwareSpreadsheet softwareElectronic common technical document eCTD validating softwareTotal quality management TQM softwareIntegrated development environment IDE softwareMicrosoft WordAdobe AcrobatAdobe AcrobatIntegrated development environment IDE softwareMasterControl softwareAris Global RegisterDatafarm eCTDGatekeeperDoubleBridge ROSETTA PyramidGlobalSubmit REVIEWImage Solutions ISIPublisherOctagon ViewPoint eCTD CompleteSAP EHS ManagementSoftware development toolsAxway eSubmissionsDatafarm S-CubedDoubleBridge ROSETTA SceptreGlobalSubmit VALIDATELorenz DocuBridgePilgrim Regulatory SubmissionDocument publishing softwareDocument publishing softwareElectronic common technical document eCTD softwareElectronic common technical document eCTD softwareElectronic common technical document eCTD viewing softwareElectronic common technical document eCTD viewing softwareMediRegs E-dition Compliance MonitorMediRegs E-dition Compliance MonitorMediRegs Regulation and Reimbursement SuiteMediRegs Regulation and Reimbursement SuiteXML authoring softwareTake Solutions PharmaReady Document Management SystemTake Solutions PharmaReady Document Management SystemMicrosoft PowerPointStructured query language SQLStructured query language SQLMicrosoft Office softwareMicrosoft Office softwareMicrosoft PowerPointMicrosoft WordWeb browser software
Chief Executives
Medium38.73%
Determine and formulate policies and provide overall direction of companies or private and public sector organizations within guidelines set up by a board of directors or similar governing body. Plan, direct, or coordinate operational activities at the highest level of management with the help of subordinate executives and staff managers.
Chief Sustainability Officers
Medium50.38%
Communicate and coordinate with management, shareholders, customers, and employees to address sustainability issues. Enact or oversee a corporate sustainability strategy.
Public Relations Managers
Medium48.75%
Plan, direct, or coordinate activities designed to create or maintain a favorable public image or raise issue awareness for their organization or client.
Administrative Services Managers
Medium45.13%
Plan, direct, or coordinate one or more administrative services of an organization, such as records and information management, mail distribution, and other office support services.
Security Managers
Medium48.21%
Direct an organization's security functions, including physical security and safety of employees and facilities.
Quality Control Systems Managers
Medium50.15%
Plan, direct, or coordinate quality assurance programs. Formulate quality control policies and control quality of laboratory and production efforts.
Natural Sciences Managers
Medium46.02%
Plan, direct, or coordinate activities in such fields as life sciences, physical sciences, mathematics, statistics, and research and development in these fields.
Clinical Research Coordinators
Medium49.27%
Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
Compliance Managers
Medium47.57%
Plan, direct, or coordinate activities of an organization to ensure compliance with ethical or regulatory standards.
Environmental Compliance Inspectors
Medium52.09%
Inspect and investigate sources of pollution to protect the public and environment and ensure conformance with Federal, State, and local regulations and ordinances.
Government Property Inspectors and Investigators
Medium45.48%
Investigate or inspect government property to ensure compliance with contract agreements and government regulations.
Regulatory Affairs Specialists
Medium50.05%
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
Project Management Specialists
Medium52.50%
Analyze and coordinate the schedule, timeline, procurement, staffing, and budget of a product or service on a per project basis. Lead and guide the work of technical staff. May serve as a point of contact for the client or customer.
Management Analysts
Medium51.36%
Conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively. Includes program analysts and management consultants.
Financial Risk Specialists
Medium55.00%
Analyze and measure exposure to credit and market risk threatening the assets, earning capacity, or economic state of an organization. May make recommendations to limit risk.
Financial Examiners
Medium47.79%
Enforce or ensure compliance with laws and regulations governing financial and securities institutions and financial and real estate transactions. May examine, verify, or authenticate records.
Clinical Data Managers
Medium57.40%
Apply knowledge of health care and database management to analyze clinical data, and to identify and report trends.
Health and Safety Engineers, Except Mining Safety Engineers and Inspectors
Medium45.53%
Promote worksite or product safety by applying knowledge of industrial processes, mechanics, chemistry, psychology, and industrial health and safety laws. Includes industrial product safety engineers.
Environmental Scientists and Specialists, Including Health
Medium51.39%
Conduct research or perform investigation for the purpose of identifying, abating, or eliminating sources of pollutants or hazards that affect either the environment or public health. Using knowledge of various scientific disciplines, may collect, synthesize, study, report, and recommend action based on data derived from measurements or observations of air, food, soil, water, and other sources.
Health Information Technologists and Medical Registrars
Medium57.81%
Apply knowledge of healthcare and information systems to assist in the design, development, and continued modification and analysis of computerized healthcare systems. Abstract, collect, and analyze treatment and followup information of patients. May educate staff and assist in problem solving to promote the implementation of the healthcare information system. May design, develop, test, and implement databases with complete history, diagnosis, treatment, and health status to help monitor diseases.