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Manager, Regulatory Affairs at Collegium Pharmaceutical - ApplyBlast

Manager, Regulatory Affairs

Collegium Pharmaceutical

3 months ago

3.1 on Glassdoor

Stoughton, Massachusetts, United States

Hybrid

Full Time

Manager

0 applicants

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About this role

The Manager, Regulatory Affairs at Collegium Pharmaceutical provides regulatory support for marketed products and development programs, ensuring compliance with FDA, EMA, Health Canada, and other authorities. The role collaborates cross‑functionally with Medical, Commercial, Legal, Compliance, and Technical Operations to prepare and maintain IND, NDA, and other regulatory submissions and filings.

Responsibilities

Prepare IND and NDA submissions to regulatory agencies
Ensure submissions comply with FDA, EMA, ICH, Health Canada, and MHRA requirements
Manage collection and coordination of all material necessary for regulatory filing
Serve as primary interface for electronic submissions via FDA’s submission gateway
Oversee labeling and maintenance of regulatory files and document systems

Skills

Qualifications

Bachelor's degreeMaster's degree

About Collegium Pharmaceutical

collegiumpharma.com

Headquarters

Stoughton, Massachusetts, United States

Company Size

201-500 employees

View Profile

Collegium Pharmaceutical is a diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The company builds a portfolio of differentiated medications spanning multiple therapeutic areas, including pain management and ADHD, with recent growth including the acquisition of AZSTARYS from Corium Therapeutics. Headquartered in Stoughton, Massachusetts, Collegium is publicly traded on NASDAQ (COLL) and combines development, regulatory, and commercial capabilities to bring meaningful medicines to patients across the U.S.