I am currently working with a global CRO looking to grow their business across Asia Pacific, providing strategic and tactical support in all aspects of regulatory affairs, from preclinical, CMC and clinical development for drugs, biologics, devices and other products. They are looking for an Associate Director of Regulatory Affairs to pioneer the Regulatory team in China.
This is an exciting opportunity to pioneer the Regulatory Affairs team, with alot of growth potential and career progression.
- Develop and execute China regional strategies and contingencies
- Lead strategies with US pathways
- Prepare study documentation to China Regulatory Authorities
- Create formal networks internally and externally
- Participate in project development and regualtory strategy planning sessions
- Exeprience in pharmaceutical, biotech or Regulatory Affairs or Drug Development in China.
- Experience interacting with the NMPA required, experience with other regulatory agencies preferred
- Exceptionally keen attention to detail
- Excellent communciation skills
If you are interested, please apply with your CV attached.