Senior Director, Regulatory Affairs CMC

Senior Director role leading regulatory chemistry, manufacturing, and controls (CMC) strategy for a biopharmaceutical company. Responsible for regulatory submissions, compliance interpretation, and cross-functional collaboration to achieve global drug approvals for small and large molecules.

Responsibilities

• Develop and execute regulatory CMC strategies for drug submissions across multiple development phases and geographies
• Draft, review, and prepare CMC regulatory documents and meeting plans with health authorities
• Conduct due diligence assessments of potential small and large molecule drug products
• Interpret FDA, EMA, ICH, and WHO regulations to ensure compliance in regulatory filings
• Resolve technical and regulatory issues collaborating with scientists on manufacturing, impurities, formulation, and lifecycle management

Requirements

• Bachelor's degree with 10+ years pharmaceutical development and regulatory CMC experience
• Experience supporting both small and large molecule products in multinational settings
• Proven experience as regulatory affairs CMC product lead
• Deep knowledge of US, EU, Japanese drug regulations and ICH/FDA/PMDA guidelines
• Track record of agency interactions and end-to-end project management in regulatory affairs
• Advanced degree (MS, PhD, or PharmD) strongly preferred
• Strong leadership and cross-functional communication capabilities

Compensation: $222,000-$303,000 annual