Senior Director, Regulatory Affairs CMC

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.

• 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

• 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

• 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

hybrid model based in Waltham, MA or Conshohocken, PA, with a 3-day in-office requirement.