Senior Director, Regulatory Affairs CMC

Role: Senior Director of Regulatory Affairs CMC, providing strategic and operational leadership for regulatory chemistry, manufacturing, and controls activities supporting clinical trials, market registration, and post-approval submissions for biopharmaceutical products. Responsibilities: develop and execute regulatory CMC strategies across product lifecycle; oversee regulatory dossier content and ensure compliance with health authority requirements; serve as the company’s representative in global health authority meetings; support quality activities, inspections, and change management; identify and mitigate regulatory risks, and stay current with evolving global regulatory guidance. Qualifications: BS in life sciences or healthcare, with 15+ years’ regulatory CMC experience; proven expertise in global CMC development, clinical trial and commercialization support, particularly for small molecule products; strong regulatory authority interaction experience; excellent communication and negotiation skills. HighValue: extensive global CMC regulatory experience, including interactions with health authorities, regulatory dossier preparation, and lifecycle management; focus on small molecule pharmaceuticals; involvement in regulated environments with a deep understanding of regulatory guidelines. WorkSetup: hybrid model based in Waltham, MA or Conshohocken, PA, with a 3-day in-office requirement.