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Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
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.
Global Head of Regulatory Affairs CMC at Innovent Biologics
RAC holder since 2021
My rigorous academic training in Pharmaceutics and years of working experience in private sectors as a pharmaceutical scientist had prepared me well for a career in regulatory affairs. In addition, my thirteen years of regulatory review experience in the US Food and Drug Administration (FDA) gave me a wealth of regulatory experience in handling challenging scientific and regulatory issues. I particularly like the strategic planning aspect of regulatory affairs. I think regulatory operation is also interesting as it entails knowledge and experience in both science and regulation.
I am still new to my job—I joined Innovent Biologics a few months ago. I am leading a global RA CMC team which will grow tremendously in the coming years. As Innovent Biologics is expanding rapidly globally, we strive to excel by attracting world-class talents.
One of my FDA former colleagues introduced RAPS to me. RAC certification is widely recognized in the regulatory affairs professional community as it has been known to open up many new career possibilities. For this reason and also because of my decade long regulatory review and inspection experience, I decided to register for the RAC exam and explore more career opportunities in the regulatory affairs area.
Be a lifelong learner. RA professionals are expected to have broader knowledge, as they need to interact on daily basis with the global health authorities as well as various internal stakeholders. Therefore, developing a learning mindset at work is essential as a RA professional.