Plans, directs or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
This career is part of the Business Management and Administration cluster General Management pathway.
A person in this career:
- Directs the preparation and submission of regulatory agency applications, reports, or correspondence.
- Reviews all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Provides regulatory guidance to departments or developments project teams regarding design, development, evaluation, or marketing of products.
- Formulates or implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Communicates regulatory information to multiple departments and ensures that information is interpreted correctly.
- Manages activities such as audits, regulatory agency inspections, or product recalls.
- Develops regulatory strategies and implementation plans for the preparation and submission of new products.
- Provides responses to regulatory agencies regarding product information or issues.
- Maintains current knowledge of relevant regulations, including proposed and final rules.
- Investigates product complaints and prepares documentation and submissions to appropriate regulatory agencies as necessary.