Manager, Regulatory Affairs

Prepare Investigational New Drug (IND) and New Drug Application (NDA) submissions to the FDA and ensure compliance with FDA, EMA, ICH, Health Canada, and MHRA regulations. Collaborate with Medical, Commercial, Legal, and Technical Operations stakeholders to compile, coordinate, and file required information for marketed products and development programs. Manage labeling for approved and investigational products, oversee regulatory file maintenance, and prepare annual reports and adverse drug experience reports. Serve as the primary interface for electronic submissions via FDA's gateway. Work in a hybrid role requiring onsite presence in Stoughton, MA on Tuesdays, Wednesdays, and Thursdays.