Discovering a Regulatory Affairs Career

Kiran Gulati and Susan Carino

Overcoming failure can set you on a new and better path.”

In the last 13 years, Susan Carino, principal consultant with Integrated Project Management Company, Inc., has helped 17 clients keep pace with the evolving field of regulatory affairs. She has consulted on a variety of projects including new discoveries related to oncology immunotherapies, retinal and blood diseases, microbiome disorders, orphan diseases, medical device automation, and genomic-based diagnostic testing.

“I love the fact that I’m still in science but not a scientist,” says Carino who has both a bachelor’s and a master’s degree in Chemistry, as well as a master’s degree in Business Administration. “I’m contributing to science without having to be a scientist in the lab.”

Finding her passion in regulatory affairs

Carino’s passion to help companies with their regulatory challenges developed only after she left a doctoral program without completing a dissertation. While she once described it a “devastating,” six-year effort, she now sees that time as a turning point that set her on a better career path.

“My strong scientific background has helped me immensely in my career as a liaison on behalf of scientists to manage projects that help save lives and improve the quality of life for patients,” she says.

Carino went on to earn a Project Management certificate from UC Berkeley Extension and a Project Management Professional (PMP)® designation from Project Management Institute (PMI). She worked in the field, eventually pairing project management with regulatory affairs.

“I always walked away from my client projects in kindred spirits with the regulatory team member,” she says. “I bonded closest with them, which made me curious to learn more about why I was drawn to regulatory affairs.”

Joining a Professional Network

Because she was working full-time, it took three years to complete the UCSC Extension Regulatory Affairs certificate. She studied for six months to take the Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC) test and passed on the first try. RAPS invited her to be an exam reviewer the following year and she’s been volunteering for the organization ever since.

Getting involved with the RAPS organization has been a professional and personal turning point for Carino, who has forged important friendships and professional connections with other RAPS volunteers all over the world.

“I’ve always had a desire to help others. Our local RAPS chapter has given me the opportunity to help people pass the RAC exam by hosting a study group on Saturdays in the summer of 2017 for the US RAC and in 2018 for the EU RAC,” she says. “The more I get involved with RAPS the more fun I have and the more great people I meet and connect with professionally.”

Carino now serves as chair of the San Francisco Bay area chapter of RAPS where she has been spearheading membership growth through educational networking events throughout the greater Silicon Valley area.

Connecting UCSC Extension with RAPS

In that position she’s involved with many of her former UCSC Extension Regulatory Affairs certificate instructors including program Chair Kiran Gulati and numerous other certificate program graduates. The integration of instructors and students in the RAPS organization strengthens the regional career guidance network.

“I am so thankful for the commitment of UCSC Extension to applied skills. It is harmonious with the spirit of RAPS. It helps to keep people on the cutting edge.”

The ongoing demand for regulatory affairs professionals is especially strong in today’s economy and Carino has returned often to UCSC Extension to share her experience with prospective students, help with study groups, and meet with instructors.

“All of the professors I’ve had have been very helpful,” she says. “Kiran’s gone above and beyond to strengthen the collaboration with the students and support the students long after they’ve left.” It’s more than a certificate program, she says. “It’s a way of life that can help your career. That’s different from many of the institutions that I’ve been a part of.”

Read more on the topic “Common Regulatory Submission Pitfalls and Ways to Avoid Them,” a white paper by Carino.




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