Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.
Careers in Regulatory Affairs
There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:
- Regulatory affairs associate
- Regulatory affairs specialist
- Regulatory affairs senior specialist
- Regulatory affairs project/program manager
- Regulatory affairs manager
- Regulatory affairs director
- Regulatory Affairs vice president
These regulatory professionals play a critical role in the development and distribution of medical technological advancements and disease-free food, improving people’s health and welfare around the world.