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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Director, GRA-CMC at Atea Pharmaceuticals, Inc
RAC holder since 2013
My experience in supporting late-stage drug development as a formulator kindled my interest in Regulatory Affairs. What I like the most in regulatory affairs is that it gives me an opportunity to see the full lifecycle of a drug product. As part of my career development, my then employer provided me with an internship within the regulatory affairs department. After a successful six months of internship, I was able to transition into the regulatory affairs group and pursue a career in regulatory. I was fortunate to have great mentors who guided me in making the transition and great to see them still continue to provide me guidance when I need one.
I sought out RAC certification for professional development purposes and to enhance my knowledge in regulatory affairs.
On a typical day, I spend my time developing regulatory strategies related to chemistry, manufacturing, and controls (CMC) by interacting with the development teams and clinical teams to enable clinical studies in a timely manner by keeping patients in mind along with business objectives. Also, I constantly work towards improving processes for efficiency purposes.
Yes. Preparing for the exam helped me to understand aspects other than CMC. It not only improved my understanding on drug product development but also helped me to develop an appreciation on how clinical, CMC development, and non-clinical information feed into one another in bringing a drug to the market.
Develop a passion for regulatory affairs and equip by taking suitable courses to gain understanding. Find a mentor and network a lot. Don’t shy away from asking questions as there are many aspects in regulatory affairs. Constantly challenge yourself and take on every opportunity that comes your way. It is more hands-on and you will learn something new every day—be it an early or late stage program. Be nimble and agile as the regulatory landscape keeps evolving and enjoy the ride!