Recruiter's Glossary

Examples: QA/QC • GLP • Serialization

Regulatory Affairs

Term from Pharmaceutical Services industry explained for recruiters

Regulatory Affairs is a crucial department in pharmaceutical and healthcare companies that ensures all products meet legal requirements before they can be sold. Think of them as the bridge between companies and government agencies like the FDA. They help guide products (medicines, medical devices, etc.) through the approval process, maintain compliance with laws, and keep all required paperwork in order. Without Regulatory Affairs professionals, new medicines and medical products couldn't make it to market legally. This field is sometimes called "RA," "Regulatory Compliance," or "Regulatory Services."

Examples in Resumes

Led Regulatory Affairs team in successful FDA approval of new drug application

Managed Regulatory Affairs submissions for medical devices across European and Asian markets

Coordinated with Regulatory Affairs department to ensure compliance with international healthcare regulations

Served as RA specialist for company's portfolio of generic medications

Typical job title: "Regulatory Affairs Professionals"

Also try searching for:

Regulatory Affairs Specialist Regulatory Affairs Manager Regulatory Compliance Officer RA Associate Regulatory Strategy Manager Drug Safety Specialist Regulatory Submissions Specialist

Where to Find Regulatory Affairs Professionals

Professional Associations

Job Boards

Professional Networks

Example Interview Questions

Senior Level Questions

Q: How would you handle a situation where regulatory requirements conflict between different countries for a product launch?

Expected Answer: A senior professional should discuss their experience in managing global submissions, describing how they would analyze requirements, develop market-specific strategies, and possibly suggest modifying the product or documentation to meet all requirements while maintaining project timelines.

Q: How do you stay current with changing regulations and ensure your team maintains compliance?

Expected Answer: Should explain their approach to monitoring regulatory updates, implementing training programs, maintaining documentation systems, and developing strategies to adapt to new requirements proactively.

Mid Level Questions

Q: What experience do you have with FDA submissions?

Expected Answer: Should be able to describe different types of submissions (NDAs, ANDAs, 510(k)s), explain the basic submission process, and discuss their role in preparing and managing these submissions.

Q: How do you ensure effective communication between regulatory affairs and other departments?

Expected Answer: Should discuss experience in working with R&D, manufacturing, and marketing teams, explaining how they translate regulatory requirements into actionable guidelines for other departments.

Junior Level Questions

Q: What do you know about the drug development process and regulatory requirements?

Expected Answer: Should demonstrate basic understanding of clinical trials phases, regulatory submission types, and the role of regulatory affairs in product development.

Q: How do you organize and maintain regulatory documentation?

Expected Answer: Should explain basic document control practices, understanding of regulatory dossiers, and familiarity with electronic submission systems.