Manager, Regulatory Affairs

Scorpion Therapeutics; Boston (MA); On-site; USD 132,000 - 158,000; Full time

Job summary

Collegium Therapeutics is seeking a Regulatory Affairs Manager to provide regulatory support for marketed products and development programs, partnering cross-functionally with Medical, Commercial, Legal & Compliance, and Technical Operations to file and maintain applications in compliance with FDA and global regulations.

Responsibilities include preparing IND and NDA submissions to FDA, ensuring compliance across agencies, coordinating with stakeholders, maintaining regulatory files, and

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.

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 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.

Skills

Regulatory knowledge

Communication

Microsoft Office

Education

Bachelor’s degree

Master’s degree

Tools

Document management systems

Electronic publishing

Job description

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