Job Details

Competitive Salary
Job Type
Piers Atkinson
Contact email
Email Piers
9 months ago
A new entrant to Asia, this Biopharma is looking for a Regulatory Affairs Associate Director.

You will be in charge of all things regulatory in APAC where currently they don’t have anything, so you will be able to set things up how you like. It’s still a hands on role, won’t be managing teams of people but will offer you the chance to have a real say and impact on the APAC orgnisation.

They offer a strong pipeline of oncology products to get stuck into, have already licensed their first product so are financially stable and will let you do things your way.

The Regulatory Affairs Associate Director will be responsible for:
  • Develop strategy for and oversee the preparation of APAC regulatory submissions
  • Lead clinical trial applications (CTAs) as well as APAC Marketing Authorisation Applications (MAA)
  • Leading APAC Regulatory Agency interactions
  • Managing and working with CROs  and providing regulatory support in the APAC region

The Regulatory Affairs Associate Director will be / have:
  • Industry experience in with drug or therapeutic biologic products. Experience in oncology strongly preferred
  • Regional APAC experience
  • Experience in the preparation of regulatory documentation to support CTAs, MAAs, oversight of CROs or contractors

If you feel you would be suitable then please apply now.

Reg No. R1871342
BeathChapman Pte Ltd
Licence no. 16S8112