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Regulatory Affairs Specialists - 13-1041.07

O*NET-SOC Description

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.

Sample of Reported Job Titles

  • Drug Regulatory Affairs Specialist
  • Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist)
  • Regulatory Affairs Analyst
  • Regulatory Affairs Associate
  • Regulatory Affairs Consultant
  • Regulatory Affairs Specialist
  • Regulatory Affairs Strategy Specialist
  • Regulatory Associate
  • Regulatory Services Consultant
  • Regulatory Submissions Associate

SOC Occupation Groups

13-0000 Business and Financial Operations Occupations
13-1000 Business Operations Specialists
13-1040 Compliance Officers
13-1041.00 Compliance Officers
13-1041.07 Regulatory Affairs Specialists

Related Occupations

Tasks

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Compile and maintain regulatory documentation databases or systems.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Coordinate recall or market withdrawal activities as necessary.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Develop or conduct employee regulatory training.
  • Develop or track quality metrics.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Obtain clearances for the use of recycled plastics in product packaging.
  • Participate in internal or external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  • Write or update standard operating procedures, work instructions, or policies.

Detailed Work Activities

  • Advise others on legal or regulatory compliance matters.
  • Analyze environmental regulations to ensure organizational compliance.
  • Communicate with government agencies.
  • Coordinate regulatory documentation activities.
  • Correspond with customers to answer questions or resolve complaints.
  • Establish organizational guidelines or policies.
  • Evaluate applicable laws and regulations to determine impact on organizational activities.
  • Examine financial records or processes.
  • Examine product information to ensure compliance with regulations.
  • Explain regulations, policies, or procedures.
  • Maintain data in information systems or databases.
  • Monitor business indicators.
  • Obtain documentation to authorize activities.
  • Oversee business processes.
  • Prepare financial documents.
  • Prepare regulatory or compliance documentation.
  • Train personnel in organizational or compliance procedures.
  • Update knowledge of legal or regulatory environments.

Military Crosswalk Titles

  • Financial Management and Comptroller (Air Force - Enlisted)
  • Financial Management and Comptroller Apprentice (Air Force - Enlisted)
  • Financial Management and Comptroller Craftsman (Air Force - Enlisted)
  • Financial Management and Comptroller Helper (Air Force - Enlisted)
  • Financial Management and Comptroller Journeyman (Air Force - Enlisted)
  • Financial Management and Comptroller Superintendent (Air Force - Enlisted)
  • Interior Communications Electrician (Navy - Enlisted)

Apprenticeship Crosswalk Titles

No information available.

DOT Crosswalk Titles

No information available.