January 2017: Phillip Vogeley started his first Regulatory Affairs course
6 months later: Received a regulatory internship at BioMarin Pharmaceutical
4 months later: Hired full time as a Regulatory CMC Associate at the same company
3 months later: Completes the Professional Program in Regulatory Affairs
One year and one month: The fast-track timeframe for Phillip to take his B.S. in Biochemistry and Molecular Biology from UC Davis and jump-start a career in regulatory affairs. And this career path comes naturally to Phillip, as he’s able to combine his science background with a deeper understanding of the business and corporate strategy of the biotechnology industry.
“Thanks to my certificate,” Phillip says, “I’m now working in an amazingly complex and rewarding role.”
That position sees Phillip developing global science-based regulatory strategies, creating high-quality submissions, and promoting positive interactions with global colleagues and regulatory authorities for the biotech company’s small-molecule portfolio.
“Everything I do is in support of receiving timely approvals for BioMarin’s innovative therapies,” Phillip adds. “A typical day can include many things, but most commonly I’m communicating with cross-functional teams in order to put together submissions—a new submission, a variation or responses to questions—that go to health authorities.”
Thanks to my certificate, I’m now working in an amazingly complex and rewarding role.
In order to gain a comprehensive understanding of regulatory affairs, Phillip needed an educational partner that met his various needs.
“I chose UC Berkeley Extension for many reasons, including reasonable cost, close proximity to work, convenient class schedules and from reading positive testimonials,” Phillip explains. “I expected these classes to be full of professionals looking for career changes—and many of them were doing just that. But I also met a lot of people who were simply interested in learning more about regulatory affairs to serve other job functions.”
Those interactions with folks from various biotechnology companies and positions—as well as learning from professionals who bring their own real-world experiences to the class—gave Phillip the right mix of the fundamentals and applied knowledge.
Earning the certificate validated that I understood regulatory fundamentals.
Lessons learned in class would soon re-appear for Phillip in his work. While a homework assignment may have felt to be just that, the experience of working through that project would soon become one of many job responsibilities.
“I was drafting a cover letter to be submitted to a health agency. The assignment was given to us in class to help us practically apply what we were learning. Not too long after, I was hired as a Regulatory Affairs Associate and had to draft an actual cover letter for eventual submission to a health agency. I felt more comfortable knowing that I had already done something similar in class.”
Not only was it the tangible learnings that showed Phillip’s know-how and grasp of the regulatory affairs domain, but the program as a whole validated his understanding of the various intricacies of his work.
“The program allowed me to prove to myself and others that I was serious about pursuing this opportunity,” Phillip adds. “Earning the certificate validated that I understood regulatory fundamentals.”
If you’re serious about pursuing a career in regulatory affairs, Phillip highly recommends this program. “You will not only learn about regulatory affairs, but you will be able to decide if this is for you. Earning the certificate will show regulatory professionals that you are serious about this field.”