Director Regulatory Affairs CMC

Location: Wilmington Salary: competitive
Sector: R&D, Regulatory Affairs Type: Permanent

The Company: A US-based global bio-pharmaceutical company is looking to hire a Director of Regulatory Affairs CMC to help lead global expansion efforts for both their approved and in-development assets. You will report directly into the SVP of Regulatory Affairs, and provide the top-level regulatory CMC strategy for the company. You will lead and manage vendor relationships and interactions with the FDA and global health authorities. As the department continues to expand, you will have the opportunity to lead both cross-functionally and directly.

Required Skillset:

  • Educational Experience Required: Minimum of a Bachelor's in a scientific discipline, Master's or Ph.D. preferred
  • Must have a minimum of 8 years of experience in Regulatory Affairs CMC or 6 years of Regulatory Affairs CMC with relevant experience in drug development/chemistry
  • Experience leading and building submissions for both small and large molecules
  • Management of interactions with FDA and Global Health Authorities
  • Experience working on global, cross-functional teams

Location: Greater Philadelphia Area

Salary Range: $160,000- $185,000

Why Work Here?

This opportunity will provide you with the opportunity to join a successful and growing Regulatory CMC group as a strategic leader as the company continues to expand in the US and globally. You will work in a start-up style environment, but with a diverse portfolio of assets, both approved and in- development. This company prides itself on its collaborative culture and focus on bringing novel products to the market.

Sthree US is acting as an Employment Agency in relation to this vacancy.