Careers in Regulatory Affairs Webinar Recap

posted Mar 17, 2015, 1:56 PM by Nadia Jaber   [ updated Sep 30, 2016, 2:15 PM by Alexandra Weinheimer ]

by Nadia Jaber

The Graduate Career Association hosted Patrick Finigan on March 6th 2015 via Skype to talk about careers in regulatory affairs. Dr. Finigan is currently a Chemistry Manufacturing and Control Associate at Genzyme/Sanofi.

 

How did you transition out of academia?

Patrick earned his PhD from Cold Spring Harbor Laboratories in 2011. While working for his PhD, he realized that he wanted to explore beyond academia. He adopted the principle “chance favors the prepared mind”, and thus started participating in “extra-curricular” activities. He took the Fundamentals of Bioscience Industry Program at Stony Brook, where he was introduced to various aspects of the pharmaceutical industry. He also joined the Bioscience Enterprise Club at CSHL (the equivalent of the Graduate Career Association) and learned more about alternative careers. He was interested in regulatory affairs, so he organized two seminars on the topic. He attended events at the New York Academy of Sciences, and participated in numerous career development exercises.

After completing his PhD, Patrick worked as a postdoctoral fellow for a few months until he applied for a global regulatory affairs internship at Bayer Healthcare Pharmaceuticals, an international pharmaceutical company. He received the (paid) summer internship and got a formal introduction to the field of regulatory affairs. Patrick was able to extend his internship for 1.5 years, making a place for himself at Bayer. When there were no full time positions in RA available at Bayer, he sent his résumé to a friend at Genzyme, which helped him land his current job. He reminded us that personal contact is very powerful during the job search.

 

What is Regulatory Affairs?

The field of regulatory affairs (RA) deals with laws and regulations regarding pharmaceuticals and biotechnology. The Food and Drug Administration (FDA) turns laws into enforceable regulations, and gives companies guidance on how to follow these rules and regulations. The RA department of a company ensures that the research and development side of the company is following these FDA regulations. A regulatory affairs associate acts as a liaison between these two contingencies. A major goal of the regulatory affairs department is ensuring patient safety during drug development and clinical trials.

Regulatory affairs actually encompasses a subset of specialties. For example, clinical RA deals with filing applications for clinical trials run by the company. International RA ensures that a product made in the US follows regulations in other countries. Patrick works on the chemical, manufacturing and control (CMC) side of RA, which ensures the quality of manufactured products. This involves regulating the strength, identity, purity, and potency of the product.

 

What does a CMC associate do?

In order to get FDA approval of a product, the company has to describe its strength, identity, purity, potency and quality. If the company wants to scale-up production of the product, it still needs to demonstrate these five characteristics. As a CMC associate, Patrick helps the researchers develop protocols to measure these characteristics. He also helps them troubleshoot when unexpected issues in experiments arise. Patrick’s experience in molecular biology research is particularly crucial for his success in these aspects of the job.

 

What is the lifestyle of a CMC associate like?

The starting salary for an RA associate is around $70,000, and working hours are typical (9am-5pm). As you move up, both the salary and time commitment increase. The entry level position in RA at Genzyme is called an “associate”, but titles can change at different companies.

 

What can students do now to prepare for a career in RA?

Patrick’s number one answer for this is: GET OUT OF THE LAB! Gain new experiences, skills and contacts by participating in different opportunities nearby. He advised us, “If you want a non-academic job, the worst thing you can do is have a great academic CV.” Think about different ways you can show that you are more than an academic.

One of the simplest things you can do is reach out to professionals in the field and ask for an informational interview or to shadow him/her for a day. You can also volunteer and look for internships at Bayer and elsewhere. Getting industry experience will be very important for breaking into the field. Also consider taking a business course or applying for the Fundamentals of Bioscience Industry Program on campus.

Although certifications for regulatory affairs exist, Patrick suggests saving money by simply reading the regulations (300 and 600) to become familiar with them. He believes that companies care more about hands-on experience than these certifications.

Since RA involves a lot of group work, communication and persuasion are two important skills to possess. Think about ways you can enhance and demonstrate these skills to a potential employer.

 

Can international students go into RA?

Many of the biotech and pharmaceutical companies with RA divisions are international. Thus, an international student could work overseas in the same position. In addition, some companies will sponsor non-citizens.

 

Where are RA jobs geographically located?

The main hubs for RA are located in New York, New Jersey, Boston, and the San Francisco Bay area. There are also smaller divisions in North Carolina, Seattle and San Diego. Abroad, RA jobs can be found in Europe and China.