Manager, Regulatory Affairs
Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications.
Hybrid – Boston, MA: Collegium will relocate its headquarters to One Lincoln in downtown Boston in Q1 2027. Until the move, this role will be based at our current headquarters in Stoughton, MA. Employees are required to work onsite Tuesday, Wednesday, and Thursday each week, both before and after the relocation.
POSITION OVERVIEW
The Manager, Regulatory Affairs will play a key role in providing Regulatory support for Collegium’s marketed products and development programs. They will work in a highly cross-functional manner with internal stakeholders including Medical, Commercial, Legal and Compliance, and Technical Operations to file and maintain the applications for Collegium’s marketed products and development programs in compliance with applicable regulations.
RESPONSIBILITIES
- Prepare Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA to support development pr
