Director Legal, Manufacturing Division

Role: Provide legal support to manufacturing compliance (cGMP) and regulatory interactions within a biopharma context, focusing on quality, supply chain, and manufacturing agreements. Responsibilities: advise on regulatory submissions, inspections, and compliance with cGMP; manage manufacturing-related legal risks and strategy; review regulatory documents and interactions with agencies like FDA/EMA. Requirements: JD from an accredited US law school, admission to NJ or equivalent bar; 5+ years regulatory law experience, preferably in pharma or with cGMP expertise; strong communication, analytical, and multitasking skills. HighValue: experience with pharmaceutical manufacturing, regulatory agencies (FDA, EMA), and cGMP regulations; exposure to manufacturing compliance, regulatory inspections, and pharmaceutical law. WorkSetup: hybrid in NJ or PA (Rahway, North Wales, Upper Gwynedd); 10% travel.