Thursday, September 1, 2011

Alternative careers in chemistry: regulatory affairs

In this week's chapter of "Nontraditional Careers in Chemistry"*, we're looking at regulatory affairs. What do they do? According to Lisa Balbes:
Because of stringent regulations, companies that makes pharmaceutical products, medical devices and related products are those most likely to employ people to monitor regulations in specific areas, prepare submissions to regulatory agencies, and guide a product or product line through premarket approval, manufacturing, labeling and on through to advertising and post-release surveillance. These regulatory affairs professionals are involved in the entire product cycle, from development to widespread commercial use. 
She follows the story of Lucinda, the director of the Division of Pharmaceutical Analysis, which is part of of the Center for Drug Evaluation and Research section of the FDA. Lucinda got her Ph.D. at Berkeley, took a position at Rohm and Haas, worked as a validation engineer at Sigma-Aldrich and ultimately applied (from an ad in the back of C&EN!) to a position at FDA. What does she and her group do at FDA (other than analytical chemistry?) Well:
Some of their work is "immediate response," for example, determining the quality of more than 300 samples of KI tablets (to be used by the government in the case of a dirty bomb) in only four days over a Fourth of July weekend  and determining the quality of drugs purchased from foreign Internet sites. Her division also conducts longer term research projects, such as developing new methods and criteria for assessing the quality of various dosage forms, including inhalation products and transdermal products ("patches"). 
She says, "We try to make everything we do relevant. Some of our research ends up helping when writing guidance -- for example, there is now a nasal inhalation product guidance based on some of our work, and work we did on topical products is changing the definitions of cream, ointments, lotions and so on. Our study on the quality of drugs purchased over the Internet ended up in front of Congress... We periodically talk to the other offices about what they think is missing in terms of analytical chemistry of pharmaceuticals -- such  as methods to determine bioequivalence, and so on -- and the we try to see if we can develop something."
Sounds important and interesting -- while this is probably closer than most to a typical bench career, it's still at least a little off the beaten path.

*As always, CJ's copy of the book helpfully provided by the author, Dr. Lisa Balbes.


  1. RA could use even more chemists as majority encountered come from biology or clinical backgrounds and therefore can be less in tune with Chemistry, Manufacturing and Control areas. RAs main function are to interpret guidances and regulations that are continuously changing and hope they come up with same answers as the Agencies.
    IMO Lucinda would not be classified as a RA as more a analytical chemist working as a Regulator. Although would suggest FDA could use more chemists but those with industrial experience like Lucinda are or particular value.

  2. I ended up in regulatory affairs after a decade working in the lab. I'm currently working as a reviewer, which is probably the most common job in regulatory. I ended up in this job partly by accident, but I ended up really enjoying it. It's a great job if you like details and writing. There's a lot of learning on the job - I've had to learn a lot of microbiology as well as other types of chemistry. A background in process chemistry (even a limited one like mine) can also be helpful. It can be a great career if you are a non-PhD. It can be difficult to get in the door but once you're in, there isn't the "glass ceiling" that you often encounter in pharma.

    Unfortunately, the budget situation makes things a bit difficult at the moment. However, I've read that user fees may pass for generic drugs, which would open up a lot of new positions. (No inside information - just what I read in the news.)