Regulatory Affairs Specialist  What They Do

Just the Facts

Insider Info

dotImagine if every time you took a new medicine or ate a new food product, you were taking a chance on your health. The Food and Drug Administration (FDA) tries to make sure that doesn't happen. It has regulations to ensure consumers' safety.

Someone has to make sure these standards are met. Enter the regulatory affairs associate.

dotRegulatory affairs workers help develop new drugs and other products. Then they prepare documents on the products. They give these documents to the regulatory agency. That's usually the FDA.

"There is a responsibility to both the public and the company to provide complete and accurate information," says Paola Battiston, a science professor.

Larry Gundersen heads the regulatory affairs programs at San Diego State University. "The challenge is to assist the company in adhering to these laws and regulations," he says. This must be done in a cost-effective way.

dotThese workers must understand how the different agencies work. This means keeping up with regulations that are always changing.

Gundersen says they "must also have a reasonable working knowledge of many aspects of the development process."

That means they must know about chemistry, pharmacology and toxicology. It's also important to understand manufacturing, quality control and advertising.

dotA regulatory affairs associate may work for the government, a pharmaceutical company or a consulting firm.

Martha Feldman works with a drug development company in Washington. She says this is usually a five-day, 40-hour workweek kind of job.

"Workweeks vary based upon where the company is on a submission," she adds. "As a deadline approaches, there may be 60- to 80-hour weeks."

dotThere are no major physical requirements for this job, since you are most likely to work in an office or laboratory setting. It may, however, involve going around on inspections.

Just the Facts

Want a quick overview of what this career is about?Check out Just the Facts for simple lists of characteristics.

At a Glance

Make sure standards are met

  • You may work for the government, a pharmaceutical company or a consulting firm
  • You have to keep up with changing regulations
  • This job usually requires a degree in science