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