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.