Associate Director, Regulatory Affairs CMC

  • Real Staffing
  • Washington, DC, USA
  • Aug 01, 2020
Full time Government

Job Description

This publicly-traded biotech is seeking an Associate Director, Regulatory Affairs CMC to join their highly collaborative team.

The Associate Director, Regulatory Affairs CMC will lead and collaborate with project managers on regulatory submissions and processes. The Associate Director, Regulatory Affairs CMC will join a highly collaborative environment that values transparency and communication. Together, the team will deliver exceptional quality to the market.

Responsibilities Include:

  • Lead regulatory strategies with the FDA
  • Lead regulatory CMC strategies and requirements
  • Collaborate with project managers on regulatory requirements

Skills Needed:

  • M.S./Ph.S. in life sciences
  • 5+ years of regulatory affairs experience
  • Excellent written and verbal communication skills
  • Leadership skills including high collaboration, supervisory mentorship, and consistent performance

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



Job Requirements:
This publicly-traded biotech is seeking an Associate Director, Regulatory Affairs CMC to join their highly collaborative team. The Associate Director, Regulatory Affairs CMC will lead and collaborate with project managers on regulatory submissions and processes. The Associate Director, Regulatory Affairs CMC will join a highly collaborative environment that values transparency and communication. Together, the team will deliver exceptional quality to the market. Responsibilities Include: • Lead regulatory strategies with the FDA • Lead regulatory CMC strategies and requirements • Collaborate with project managers on regulatory requirements Skills Needed: • M.S./Ph.S. in life sciences • 5+ years of regulatory affairs experience • Excellent written and verbal communication skills • Leadership skills including high collaboration, supervisory mentorship, and consistent performance