Job Details

Senior Director, Commercial Regulatory Affairs Hybrid Opportunity in Cambridge, MAMeet has partnered with a well-established, global biopharma that is looking for a Commercial Regulatory Affairs leader to join their team. Our client is focused on commercializing treatments for rare diseases and oncologic and neurologic conditions. They have 10+ approved products with a robust, late-stage clinical development pipeline.Base Pay Range $280,000.00/yr - $330,000.00/yrKey Responsibilities Be responsible for the review, approval, and submission of US promotional materials.Serve as the US Commercial Regulatory lead for all programs, managing approved drugs and development programs.Serve as the direct point of contact with the OPDP and APLB, acting as the SME for commercial regulatory affairs in cross-functional alignment meetings.Directly manage a team of in-house and contract employees.Key Qualifications Advanced degree preferred (MS, PhD, PharmD).Minimum 10 years in a Commercial Regulatory Affairs function.Experience in oncology, neurology, and/or rare diseases highly desired.Please reach out to Ryan Moran to learn more: ...@peoplewithchemistry.comSeniority Level DirectorEmployment Type Full-timeJob Function Writing/Editing, Strategy/Planning, and ScienceIndustries Biotechnology Research and Pharmaceutical Manufacturing#J-18808-Ljbffr