How do they match: Regulatory Affairs Specialists

  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Identify relevant guidance documents, international standards, or consensus standards.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

  • Advise others on legal or regulatory compliance matters.
  • Establish organizational guidelines or policies.