Andrea Chamblee

Andrea Chamblee

Senior Counsel at WSGR.com
Washington, DC

RAC holder since 1993

 

How did you get into a regulatory career?

I graduated from law school in 1986 during a terrible recession. Reagan's threats of a Federal reduction-in-force were so serious that hiring managers were crying when I cold called them. The law firms that were actually hiring wanted bankruptcy attorneys, and I wanted to protect public health. I learned about regulatory affairs, and I knew I could use my knowledge of federal procedures and enabling laws such as the Federal Food, Drugs & Cosmetics Act. I landed a job with FDA and loved it!

Where are you in your regulatory career?

I just retired after 33 years. I was able to leverage my on-the-job training in combination products and my RAC studies of specific commodities into a rewarding career, including supervising a staff of 18 and teaching the next generations of regulatory professionals.

What was an especially memorable moment for you on the job?

Thirty years after my boss, the US Food and Drug Administration (FDA) ombudsman, agreed with me and ordered the Center for Drug Evaluation and Research (CDER) to move imaging agents—a product not metabolized—to the Center for Devices and Radiological Health (CDRH), when CDER hadn't, a court ordered the move. Another very memorable moment was initiating the FDA tissue program in 1990 and watching it blossom to include so many promising therapies.

How were you introduced to RAPS? Why did you decide to become involved?

I got a chance to attend one of the first annual meetings. It was so valuable, and I found my people!

What advice would you give to someone looking to start a career in regulatory?

Read. Network. Join a study group even if you're not sure you're ready yet to take the RAC. When you’re ready to seek RAC certification, group study, practice tests, and FDA Learn will serve you well.