Manager, Regulatory Affairs

Role: Regulatory Affairs Manager supporting Collegium's marketed products and development programs, focusing on regulatory submissions and compliance. Responsibilities: prepare IND and NDA submissions for FDA, EMA, and other authorities; manage regulatory documentation, labeling, and periodic reports; collaborate with cross-functional teams (Medical, Commercial, Technical Operations); serve as primary liaison with regulatory publishers; oversee regulatory file maintenance. Requirements: Bachelor's degree (Master's preferred); 4-6 years in pharmaceutical or life sciences; strong knowledge of regulatory regulations; experience with electronic publishing and document management systems; excellent communication skills; proficiency in Microsoft Office. High-Value: focus on responsible pain management/neuropsychiatry medications, regulatory filings for marketed and development-stage products, compliance with FDA, EMA, ICH, and other agencies, and cross-functional collaboration. WorkSetup: hybrid in Boston (relocation to One Lincoln in 2027); onsite Tuesday-Thursday.