Zedong Dong

Zedong Dong, PhD

Global Head of Regulatory Affairs CMC at Innovent Biologics
Rockville, MD

RAC holder since 2021


How did you get into a regulatory career? What do you like about regulatory affairs?

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.

How long have you been at your current position? How many people report to you report?

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.

How were you introduced to RAPS? Why did you decide to become involved?

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.

What advice would you give to someone looking to start a career in regulatory?

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.