Regulatory Affairs Manager: Submissions & Compliance

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

Job summary

Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to support regulatory filings for marketed products and development programs. The role collaborates with Medical, Commercial, Legal and Compliance, and Technical Operations to ensure filings comply with FDA, EMA, ICH and other regulations.

Based in a hybrid Boston area setting, the position requires leadership, cross-functional coordination, and a proactive approach to regulatory publishing, annual reports, and lifecycle

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) required

Responsibilities

• Prepare INDs and NDAs submissions to FDA for development programs and products
• Ensure regulatory submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and others
• Collaborate with Commercial, Medical, Technical Operations and other stakeholders to plan and file information
• Manage collection and coordination of materials for regulatory filing
• Serve as primary interface with regulatory publisher for electronic submissions via FDA gateway
• Prepare IND Annual Reports, NDA Annual Reports and periodic adverse experience reports
• Oversee maintenance of regulatory files and document systems
• Manage labeling for approved and investigational products and coordinate reviews

Skills

Regulatory knowledge

FDA submissions

Document management

Communication

MS Office

Job description

Collegium Pharmaceutical is seeking a Manager, Regulatory Affairs to support regulatory filings for marketed products and development programs. The role collaborates with Medical, Commercial, Legal and Compliance, and Technical Operations to ensure filings comply with FDA, EMA, ICH and other regulations.

Based in a hybrid Boston area setting, the position requires leadership, cross-functional coordination, and a proactive approach to regulatory publishing, annual reports, and lifecycle