How do they match: Regulatory Affairs Specialists

  • Regulatory Affairs Specialists

  • Regulatory Affairs Manager
  • Regulatory Affairs Analyst
  • Regulatory Affairs Associate
  • Regulatory Affairs Consultant
  • Regulatory Affairs Coordinator
  • Regulatory Affairs Specialist
  • Regulatory Affairs Strategist
  • Regulatory Analyst
  • Regulatory Compliance Associate
  • Regulatory Compliance Specialist
  • Regulatory Engineer
  • Regulatory Services Consultant
  • Regulatory Specialist
  • Regulatory Submissions Associate
  • Drug Regulatory Affairs Specialist
  • RA Manager
  • Risk and Compliance Analyst

  • 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.

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • 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, 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 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.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • 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.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • 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.

  • Advise others on legal or regulatory compliance matters.
  • Analyze environmental regulations to ensure organizational compliance.
  • Coordinate regulatory documentation activities.
  • Evaluate applicable laws and regulations to determine impact on organizational activities.
  • Examine product information to ensure compliance with regulations.
  • Explain regulations, policies, or procedures.
  • Investigate system, equipment, or product failures.
  • Maintain data in information systems or databases.
  • Prepare regulatory or compliance documentation.
  • Review documents or materials for compliance with policies or regulations.
  • Update knowledge of legal or regulatory environments.