Regulatory Affairs Manager - IND/NDA Submissions Leader

Collegium Pharmaceutical, Inc.; Boston (MA); Hybrid; USD 132,000 - 158,000; Full time

Job summary

Collegium Pharmaceutical, Inc. is seeking a Manager, Regulatory Affairs to provide regulatory support for marketed products and development programs. The role requires cross-functional collaboration with Medical, Commercial, Legal, Compliance, and Technical Operations to file and maintain regulatory submissions in line with regulatory requirements.

Hybrid – Boston, MA; HQ relocation planned to One Lincoln in 2027. Until then, role will be based at the current headquarters in Stoughton, MA.

Qualifications

• 4–6 years of related experience in Pharmaceutical or Life Sciences.
• Strong knowledge of applicable regulations.
• Experience with document management systems and electronic publishing.
• Strong verbal and written communications skills.
• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word).

Responsibilities

• Prepare IND and NDA submissions to FDA to support development programs and Collegium marketed products.
• Ensure regulatory submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable regulatory requirements.
• Collaborate with internal stakeholders in Commercial, Medical, Technical Operations, and other business partners to plan, compile, and affect submission of required information to FDA and other relevant Health Authorities.
• Manage and drive collection and coordination of all material necessary for regulatory filing.
• 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 regular maintenance of regulatory files and document systems.
• Manage labeling for approved and investigational products, including U.S. prescribing information, clinical trial labeling, and packaging components, while coordinating cross-functional reviews to ensure regulatory compliance, accuracy, and consistency throughout the product lifecycle.

Skills

Verbal and written communications

Cross-functional collaboration

Tools

Document management systems

Electronic publishing

Microsoft Office

Job description

Collegium Pharmaceutical, Inc. is seeking a Manager, Regulatory Affairs to provide regulatory support for marketed products and development programs. The role requires cross-functional collaboration with Medical, Commercial, Legal, Compliance, and Technical Operations to file and maintain regulatory submissions in line with regulatory requirements.

Hybrid – Boston, MA; HQ relocation planned to One Lincoln in 2027. Until then, role will be based at the current headquarters in Stoughton, MA.