Manager, Regulatory Affairs
Collegium Pharmaceutical, Inc.
August 31, 2026
Remote friendly (Stoughton, MA)
United States
Corporate Functions
POSITION OVERVIEW
The Manager, Regulatory Affairs provides regulatory support for Collegium’s marketed products and development programs, working cross-functionally to file and maintain regulatory applications in compliance with applicable regulations.
RESPONSIBILITIES
- Prepare IND and NDA submissions to the FDA
- Ensure submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable requirements
- Collaborate with Commercial, Medical, Legal/Compliance, Technical Operations, and partners to plan, compile, and submit required information
- Manage collection and coordination of materials for regulatory filings
- Serve as primary interface with regulatory publisher for electronic submissions via FDA’s submission gateway
- Prepare IND Annual Reports, NDA Annual Reports, and Periodic Adverse Drug Experience Reports
- Oversee maintenance of regulatory files and document systems
- Manage labeling (U.S. prescribing information, clinical trial labeling, packaging components) with cross-functional reviews for compliance and consistency
- Uphold core values; be accountable for team goals; communicate clearly; implement continuous improvements; solve routine problems; develop skills within a narrow technical domain
- Coach others; may have direct reports
QUALIFICATIONS
- Bachelor’s degree required; Master’s degree strongly preferred
- 4–6 years related experience in Pharmaceutical or Life Sciences required
- Strong knowledge of applicable regulations
- Experience with document management systems and electronic publishing required
- Strong verbal and written communications skills
- Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required
Pay Range: $132,219–$158,400 (USD)
The Manager, Regulatory Affairs provides regulatory support for Collegium’s marketed products and development programs, working cross-functionally to file and maintain regulatory applications in compliance with applicable regulations.
RESPONSIBILITIES
- Prepare IND and NDA submissions to the FDA
- Ensure submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable requirements
- Collaborate with Commercial, Medical, Legal/Compliance, Technical Operations, and partners to plan, compile, and submit required information
- Manage collection and coordination of materials for regulatory filings
- Serve as primary interface with regulatory publisher for electronic submissions via FDA’s submission gateway
- Prepare IND Annual Reports, NDA Annual Reports, and Periodic Adverse Drug Experience Reports
- Oversee maintenance of regulatory files and document systems
- Manage labeling (U.S. prescribing information, clinical trial labeling, packaging components) with cross-functional reviews for compliance and consistency
- Uphold core values; be accountable for team goals; communicate clearly; implement continuous improvements; solve routine problems; develop skills within a narrow technical domain
- Coach others; may have direct reports
QUALIFICATIONS
- Bachelor’s degree required; Master’s degree strongly preferred
- 4–6 years related experience in Pharmaceutical or Life Sciences required
- Strong knowledge of applicable regulations
- Experience with document management systems and electronic publishing required
- Strong verbal and written communications skills
- Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required
Pay Range: $132,219–$158,400 (USD)