Regulatory Affairs

Regulatory affairs liaisons communicate directly with the FDA throughout the drug development process and manage the drug application filings. They play an important role in providing strategic regulatory advice for the company's drug development programs.

By | June 1, 2008

Personality test
• How good are your writing skills? This is a communication-intensive role where you will be writing to the Food and Drug Administration and editing large documents that team members generate.
• Can you keep up with changing regulations and apply them consistently?
• Are you a team player? Excellent diplomacy as well as tact for managing company and government interactions is required.

• High pay, excellent security. There simply are not enough experienced regulatory affairs professionals to meet the demand. As the FDA continues to increase its requirements, the number of regulatory jobs is expected to increase.
• Tangible end result. As a team leader in regulatory affairs, you can help bring a safe and efficacious product to the market that could improve people's lives.
• Plenty of job variety and science. You will be responsible for resolving many novel issues stemming from the scientific, operational, and governmental aspects of drug development.

• Pressure. Because regulatory affairs is the last step before submitting the filings to health authorities, you'll likely work overtime, putting out fires and managing crises during deadlines.
• Experience required. The job requires intimate knowledge of the drug-approval process and GxP (good practices) regulations. It's not for someone fresh out of academia, at least not without a regulatory affairs certificate.

How to get in
Join a project team working on a section of a regulatory filing. Serving as a product reviewer at the FDA isn't as lucrative as working in industry, but it gives an inside perspective that will make you highly marketable. You can also get a certificate or a master's degree in regulatory affairs.

What's next?
Most regulatory affairs professionals stay in the profession, and many go on to serve as highly paid consultants. However, career moves can include working in clinical development or medical affairs, project management, marketing, or business development.

* Salaries are estimates of the vice president level at a small- to medium-size biotechnology company.


Avatar of: PETER TAKES


Posts: 1

June 26, 2008

As a clinical research scientist who entered the regulatory affairs profession, it is important not to neglect the medical device area of regulatory affairs as a possibility as well. This actually may be suited even better for many clinical research scientists, who might have more interest in areas like "in vitro diagnostics", or surgical devices which employ basic sciences like physics. A mix of science, clinical, and the law has proven to be quite interesting, and the jobs currently most certainly abound, regardless of geographic region!

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