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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Senior Regulatory Consultant at Millipore Sigma
RAC holder since 2021
For years, I have been in technical roles—from pharmacology and medical sciences to biopharmaceutical manufacturing. As I learned and expanded my expertise in these different areas, I saw the importance of developing my regulatory expertise. Currently, I am a senior regulatory consultant with an emphasis on biopharmaceutical manufacturing and testing.
In this dynamic environment recently, many of our clients are trying to understand novel modalities—such as the new mRNA vaccines—and how to manage change during clinical development and after marketing approval. My day typically consists of training clients, helping them access information, and make decisions on generating data to help drive efficient changes and communication with regulatory bodies.
I had taken an interest in learning more and started studying for my RAC exam. I failed the first time but learned a lot and was able to pass easily the second time. I initially pursued the RAC certification for drugs to get an overall understanding of regulatory strategy and best approaches, not only for the US, but also for Europe, the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
I prepared for the RAC on my own, reading and studying from the different regulatory sources. It was likely not the best way, since it took a lot of effort. Practice questions helped. I would recommend study groups and taking part in RAC prep workshops offered by RAPS.
Understand a broad perspective of different areas, such as quality, technical and business aspects of your company. Avoid working in a silo. Collaborate with other divisions and external partners.