Regulatory Affairs Specialists
Medium50.05%
Salary Range
Low (10th %)$43,790
Median$75,670
High (90th %)$123,710
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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.
The occupation "Regulatory Affairs Specialists" has an automation risk of 50.1%, placing it roughly in the middle of the automation spectrum. The base risk for this occupation is 50.8%, reflecting that while many routine elements of regulatory compliance can be handled by advanced systems, significant portions still require specialized human judgment. This middling risk is due partly to the structured nature of much regulatory work, which involves document management, coordination, and adherence to well-established procedures—areas where automation technologies already excel. However, regulatory affairs often entail a nuanced understanding of legal, scientific, and ethical standards across different jurisdictions, preserving the need for skilled human oversight. Among the most automatable tasks for Regulatory Affairs Specialists, coordinating efforts for preparing regulatory documents or submissions is highly repetitive and data-intensive, making it suitable for automation. Similarly, communicating with regulatory agencies about pre-submission strategies or compliance requirements can be streamlined by AI-driven platforms capable of standardizing correspondence and tracking regulatory changes. The preparation or direction of additional information or responses as requested by agencies is also amenable to automation, as it frequently involves the assembly of known datasets and templated responses that automation tools can generate quickly and accurately. Conversely, the most resistant tasks involve specialized legal or scientific interpretation and adaptability. Determining the legal implications of substances like ozone-depleting chemicals or interpreting regulations surrounding the reuse and recycling of packaging waste demand contextual expertise and up-to-date legal knowledge that current AI struggles to match. Furthermore, specialists focusing on nuanced areas such as regulatory issues in agriculture—especially those involving biotechnologies or genetically modified crops—rely on complex, original thinking and the synthesis of cross-disciplinary information. This human originality (with bottleneck skill scores of 2.9% and 3.3%) forms a significant barrier to full automation, since these tasks require creative problem-solving and flexible judgment in ambiguous or evolving regulatory landscapes.
Filter by Automatable Status
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Partially Automatable
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Partially Automatable
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Partially Automatable
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Partially Automatable
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Partially Automatable
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Partially Automatable
Coordinate recall or market withdrawal activities as necessary.
Partially Automatable
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Partially Automatable
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Partially Automatable
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Partially Automatable
Identify relevant guidance documents, international standards, or consensus standards.
Partially Automatable
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Partially Automatable
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Partially Automatable
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Partially Automatable
Recommend changes to company procedures in response to changes in regulations or standards.
Partially Automatable
Participate in internal or external audits.
Partially Automatable
Compile and maintain regulatory documentation databases or systems.
Partially Automatable
Write or update standard operating procedures, work instructions, or policies.
Partially Automatable
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Automatable
Develop or track quality metrics.
Partially Automatable
Develop or conduct employee regulatory training.
Partially Automatable
Recommend adjudication of product complaints.
Partially Automatable
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Partially Automatable
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Partially Automatable
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
Partially Automatable
Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
Partially Automatable
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Partially Automatable
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Partially Automatable
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Partially Automatable
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
Partially Automatable
Reading ComprehensionActive ListeningCritical ThinkingActive LearningComplex Problem SolvingInstallationEquipment MaintenanceQuality Control AnalysisSystems EvaluationManagement of Financial ResourcesTime ManagementManagement of Material ResourcesManagement of Personnel ResourcesWritingSpeakingMathematicsScienceLearning StrategiesMonitoringSocial PerceptivenessCoordinationPersuasionNegotiationInstructingService OrientationOperations AnalysisTechnology DesignEquipment SelectionProgrammingOperations MonitoringOperation and ControlTroubleshootingRepairingJudgment and Decision MakingSystems Analysis
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
Administration and ManagementAdministrativeMechanicalBiologyEconomics and AccountingSales and MarketingCustomer and Personal ServicePersonnel and Human ResourcesProduction and ProcessingFood ProductionComputers and ElectronicsEngineering and TechnologyBuilding and ConstructionMathematicsPhysicsChemistryForeign LanguageHistory and ArcheologySociology and AnthropologyGeographyMedicine and DentistryEnglish LanguageFine ArtsPhilosophy and TheologyLaw and GovernmentTelecommunicationsCommunications and MediaTransportationPsychologyEducation and TrainingTherapy and CounselingPublic Safety and SecurityDesign
Monitoring Processes, Materials, or SurroundingsGetting InformationIdentifying Objects, Actions, and EventsProcessing InformationEvaluating Information to Determine Compliance with StandardsAnalyzing Data or InformationMaking Decisions and Solving ProblemsThinking CreativelyUpdating and Using Relevant KnowledgeDeveloping Objectives and StrategiesScheduling Work and ActivitiesOrganizing, Planning, and Prioritizing WorkPerforming General Physical ActivitiesHandling and Moving ObjectsControlling Machines and ProcessesOperating Vehicles, Mechanized Devices, or EquipmentWorking with ComputersRepairing and Maintaining Mechanical EquipmentDrafting, 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 RelationshipsAssisting and Caring for OthersSelling or Influencing OthersResolving 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 ResourcesDocumenting/Recording InformationInspecting Equipment, Structures, or MaterialsEstimating the Quantifiable Characteristics of Products, Events, or InformationJudging the Qualities of Objects, Services, or PeopleRepairing and Maintaining Electronic Equipment
LexisNexisMicrosoft DynamicsMicrosoft PowerPointMcAfeeMicrosoft ProjectMicrosoft SharePointSAP softwareWeb browser softwareMicrosoft VisioMicrosoft Visual BasicNortonLifeLock cybersecurity softwareQlik Tech QlikViewYardi softwareFileMaker ProFund accounting softwareMicrosoft OutlookRelational database management softwareAnalyse-itDataVisionMicrosoft SQL ServerMicrosoft DynamicsLexisNexisMcAfeeMicrosoft ProjectMicrosoft SharePointMicrosoft SQL ServerSAP softwareMicrosoft VisioMicrosoft Visual BasicMicroStrategyQlik Tech QlikViewTax softwareYardi softwareFileMaker ProFund accounting softwareMicrosoft OutlookRelational database management softwareAnalyse-itDataVisionIntegrated development environment IDE softwareMedical procedure coding softwareMedical procedure coding softwareHealthcare common procedure coding system HCPCSMicrosoft AccessStatistical softwareStatistical softwareAdobe AcrobatHuman resource management software HRMSAdobe AcrobatMicroStrategyIntegrated development environment IDE softwareHealthcare common procedure coding system HCPCSAtrion Intelligent AuthoringAtrion Intelligent AuthoringMicrosoft WordStructured query language SQLNortonLifeLock cybersecurity softwareTax softwareHuman resource management software HRMSMicrosoft ExcelMicrosoft ExcelMicrosoft Office softwareMicrosoft Office softwareMicrosoft PowerPointMicrosoft WordWeb browser softwareMicrosoft AccessStructured query language SQL
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.
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.
Regulatory Affairs Managers
Medium47.41%
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Compliance Managers
Medium47.57%
Plan, direct, or coordinate activities of an organization to ensure compliance with ethical or regulatory standards.
Compliance Officers
Medium53.94%
Examine, evaluate, and investigate eligibility for or conformity with laws and regulations governing contract compliance of licenses and permits, and perform other compliance and enforcement inspection and analysis activities not classified elsewhere.
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.
Equal Opportunity Representatives and Officers
Medium42.37%
Monitor and evaluate compliance with equal opportunity laws, guidelines, and policies to ensure that employment practices and contracting arrangements give equal opportunity without regard to race, religion, color, national origin, sex, age, or disability.
Government Property Inspectors and Investigators
Medium45.48%
Investigate or inspect government property to ensure compliance with contract agreements and government regulations.
Coroners
Low30.77%
Direct activities such as autopsies, pathological and toxicological analyses, and inquests relating to the investigation of deaths occurring within a legal jurisdiction to determine cause of death or to fix responsibility for accidental, violent, or unexplained deaths.
Customs Brokers
Medium58.90%
Prepare customs documentation and ensure that shipments meet all applicable laws to facilitate the import and export of goods. Determine and track duties and taxes payable and process payments on behalf of client. Sign documents under a power of attorney. Represent clients in meetings with customs officials and apply for duty refunds and tariff reclassifications. Coordinate transportation and storage of imported goods.
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.
Document Management Specialists
Medium56.74%
Implement and administer enterprise-wide document management systems and related procedures that allow organizations to capture, store, retrieve, share, and destroy electronic records and documents.
Information Security Engineers
Medium52.50%
Develop and oversee the implementation of information security procedures and policies. Build, maintain and upgrade security technology, such as firewalls, for the safe use of computer networks and the transmission and retrieval of information. Design and implement appropriate security controls to identify vulnerabilities and protect digital files and electronic infrastructures. Monitor and respond to computer security breaches, viruses, and intrusions, and perform forensic investigation. May oversee the assessment of information security systems.
Clinical Data Managers
Medium57.40%
Apply knowledge of health care and database management to analyze clinical data, and to identify and report trends.
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.
Quality Control Analysts
Medium49.25%
Conduct tests to determine quality of raw materials, bulk intermediate and finished products. May conduct stability sample tests.
Medical Records Specialists
High73.53%
Compile, process, and maintain medical records of hospital and clinic patients in a manner consistent with medical, administrative, ethical, legal, and regulatory requirements of the healthcare system. Classify medical and healthcare concepts, including diagnosis, procedures, medical services, and equipment, into the healthcare industry's numerical coding system. Includes medical coders.
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.