Good Info on Pharma Regulatory Affairs

REGULATORY AFFAIRSDrug industry relies on those who navigate the ground between development and approval
CORINNE A. MARASCO, C&EN WASHINGTON
The pharmaceutical industry is the most regulated of all industries. Think of any drug on the market today to treat a disease, a chronic condition, or even something as mundane--and confounding--as the common cold. No drug would be available without the teams of medical researchers and other specialists who worked to make sure it received Food & Drug Administration approval.
Regulatory affairs professionals are key, but perhaps overlooked, players in drug development. They are the primary communications link between the company and agencies such as FDA, and they are responsible for keeping up with the increasing scope and complexity of regulations both here and abroad.
In the pharmaceutical industry, regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols. They are the primary interpreters of the laws and regulations for other members of the company's R&D, manufacturing, and compliance staff. Regulatory affairs professionals must have a thorough understanding of the complex set of regulations within which FDA operates: 21 CFR (Code of Federal Regulations), Sections 1 through 1299. They also need to be familiar with regulations promulgated by a whole range of agencies: the Environmental Protection Agency, Federal Trade Commission, Occupational Safety & Health Administration, and Drug Enforcement Administration.
A good regulatory professional must also be aware of the subtleties of regulations worldwide. Keeping up-to-date on regulations is essential in regulatory affairs; changes in regulations can affect the clinical trials process, regulatory strategy, decisions on what kinds of trials are needed, and so forth. New areas evolve as science changes, so time is spent tracking changes in regulations all over the world. The stakes can be high; drug approvals--as well as delays or failures--are featured prominently in the media and can make or break a company.
Although the work emphasizes regulatory knowledge, it's not just for wonks. Scientific training is also valued and helpful. "Employers are looking for people who understand the science that's driving the process," says Sherry Keramidas, executive director of the Regulatory Affairs Professional Society. "Understanding the clinical process and some of the challenges of clinical care helps regulatory affairs professionals understand the clinical trials process and what is or is not possible," she explains.
Bonnie Charpentier, a Ph.D. chemist and vice president of regulatory affairs at Genitope, agrees. "The field of regulatory affairs has become increasingly more science- and issue-based and less rote and bureaucratic, as the speed of the pharmaceutical and biologics development has increased and the science has become more complex. A regulatory professional now spends more time on substantive scientific and medical issues and on planning for the experiments and clinical studies to achieve approval.
"Currently there is a need for regulatory professionals," Charpentier says. "To do the job well requires one to be a generalist, comfortable working across a range of scientific disciplines, and competent in asking questions and defining answers."


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