Manager, Regulatory Affairs

Role: Regulatory Affairs Manager supporting Collegium's marketed products and development programs. Responsibilities: prepare IND and NDA submissions, ensure compliance with FDA, EMA, ICH, and other global regulatory standards, coordinate with internal stakeholders on regulatory filings, manage submission materials and electronic submission processes, oversee regulatory documentation including annual and periodic reports, and maintain product labeling compliance. Requirements: Bachelor’s degree (Master’s preferred), 4-6 years’ experience in pharma or life sciences, strong knowledge of regulations, experience with document management and electronic publishing, proficient in Microsoft Office, excellent communication skills. HighValue: focus on U.S. and international regulatory submissions for biopharmaceutical products, with responsibilities spanning regulatory documentation, labeling, and compliance. WorkSetup: hybrid in Boston, MA, with onsite presence required Tuesdays to Thursdays.