Regulatory Affairs Managers

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Provide responses to regulatory agencies regarding product information or issues.
• Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.