Recruiter's Glossary

Examples: NDA • Method Validation • Target Identification

Regulatory Affairs

Term from Pharmaceutical Research industry explained for recruiters

Regulatory Affairs is a crucial business function that helps pharmaceutical and healthcare companies get their products approved by government agencies like the FDA. Think of it as being the bridge between companies and government regulators. These professionals make sure new medicines and medical devices follow all the rules and get the proper approvals before they can be sold to the public. They handle the paperwork, requirements, and communication with regulatory agencies to make sure products are both safe and legal to sell. This role is sometimes also called "Regulatory Compliance" or "Regulatory Services."

Examples in Resumes

Led Regulatory Affairs team in successful FDA submission for new drug application

Managed Regulatory Affairs strategy for medical device approvals in European markets

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

Prepared Regulatory submissions for Phase I-III clinical trials

Typical job title: "Regulatory Affairs Professionals"

Also try searching for:

Regulatory Affairs Manager Regulatory Affairs Specialist Regulatory Affairs Associate Regulatory Compliance Officer 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 develop a regulatory strategy for a new drug entering multiple global markets?

Expected Answer: A senior candidate should explain how they would analyze different country requirements, create timelines, coordinate with various departments, and manage risk across multiple regulatory submissions. They should mention experience with different health authorities and strategic planning.

Q: Tell me about a challenging regulatory submission you managed and how you handled it.

Expected Answer: Look for answers showing leadership in complex situations, problem-solving abilities, and successful interaction with regulatory agencies. They should demonstrate experience managing teams and handling high-stakes submissions.

Mid Level Questions

Q: What experience do you have with FDA submissions?

Expected Answer: Candidate should be able to describe different types of submissions (like INDs, NDAs, or 510(k)s), explain the basic process, and share examples of submissions they've worked on.

Q: How do you stay current with changing regulations?

Expected Answer: Should mention specific resources they use, professional associations they belong to, and examples of how they've adapted to regulatory changes in their work.

Junior Level Questions

Q: What do you understand about the drug development process?

Expected Answer: Should show basic understanding of clinical trial phases, regulatory requirements, and the general timeline of drug development and approval.

Q: What are the main responsibilities of a Regulatory Affairs professional?

Expected Answer: Should be able to explain basic duties like maintaining documentation, assisting with submissions, and communicating with regulatory agencies.