Connecting...

Manager of Regulatory Affairs, CMC

  • Job type Permanent
  • Salary competitive
  • Location Los Angeles, California
  • Sector Regulatory Affairs

With an exciting company that is currently at the forefront of cancer immunotherapy.

Responsibilities

  • Manage the entire lifecycle of a program (IND, IMPD, BLAA, MAA)
  • Interpret regulatory guidelines to ensure that regulatory submissions are in compliance with applicable regulations
  • Prepare Module 3 for filing
  • Provide CMC regulatory strategy for any proposed changes

Must Have Skills

  • Bachelor's degree, 3-5 years of US reg experience
  • Must be familiar with all stages (pre-IND through commercialization)
  • Knowledgeable on technical regulatory guidelines
  • Experience with Module 3
  • Innovative/adaptive thinker
  • Independent worker that requires little hand-holding

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