Regulatory Affairs Manager, Global Submissions

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

Job summary

Collegium Pharmaceutical, Inc. is seeking a Manager of Regulatory Affairs to provide regulatory support for marketed products and development programs.

You will work cross-functionally with Medical, Commercial, Legal and Compliance to file and maintain applications with global regulators. Responsibilities include preparing IND/NDA submissions, ensuring compliance with global regulations, coordinating with stakeholders, managing filing materials, and maintaining regulatory documents.

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 the FDA to support development programs and Collegium marketed products.
• Ensure regulatory submissions comply with FDA, EMA, ICH, Health Canada, MHRA, and others.
• Collaborate with Commercial, Medical, Technical Operations, and other partners to plan submissions.
• Manage and drive collection of all material for regulatory filing.
• Serve as primary interface with regulatory publisher for FDA submissions.
• 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 and coordinate cross-functional reviews.
• Uphold Collegium’s Core Values and deliver team goals.
• Communicate clearly with explanations and clarifying questions.
• Implement continuous improvements and solve routine problems.
• Develop skills within a narrow technical domain; provide coaching.

Skills

Regulatory knowledge

Verbal communication

Written communication

Attention to detail

Tools

Document management systems

Electronic publishing

Microsoft Office

Job description

Collegium Pharmaceutical, Inc. is seeking a Manager of Regulatory Affairs to provide regulatory support for marketed products and development programs.

You will work cross-functionally with Medical, Commercial, Legal and Compliance to file and maintain applications with global regulators. Responsibilities include preparing IND/NDA submissions, ensuring compliance with global regulations, coordinating with stakeholders, managing filing materials, and maintaining regulatory documents.