Manager, Regulatory Affairs

Position Overview

The Manager, Regulatory Affairs provides regulatory support for Collegium’s marketed products and development programs, partnering cross-functionally with Medical, Commercial, Legal & Compliance, and Technical Operations to file and maintain applications in compliance with applicable regulations.

Responsibilities

• Prepare Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA
• Ensure submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and other applicable requirements
• Collaborate with internal stakeholders to plan, compile, and submit required information to FDA and other health authorities
• Manage collection and coordination of materials necessary 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 for approved and investigational products (U.S. prescribing information, clinical trial labeling, packaging components) with cross-functional review
• Uphold Core Values; be accountable for delivery of team goals
• Communicate clearly; implement continuous improvements and solve routine problems
• Develop skills within a narrow technical domain; coach others (may include direct reports)

Qualifications

• Bachelor’s degree required; Master’s degree strongly preferred
• 4–6 years of 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 communication skills
• Proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word) required

Pay Range: $132,219 USD - $158,400 USD