Senior Director, Regulatory Affairs CMC

Senior Director, Regulatory Affairs CMC, leading global regulatory strategies for drug substance and product lifecycle management across small and large molecules.

Responsibilities include developing and executing regulatory CMC plans, guiding submissions for clinical, marketing, and post-approval stages, and liaising with regulatory agencies such as FDA, EMA, and PMDA. Tasks also involve conducting due diligence, preparing for regulatory meetings, and ensuring compliance with international guidelines.

Requirements:
Bachelor’s degree, 10+ years in pharmaceutical development and regulatory CMC, with experience in manufacturing process development, impurity control, and global regulations. Proven ability to manage complex projects, lead cross-functional teams, and communicate effectively with regulators.

Preferred:
Advanced degree (MS, PhD, PharmD).

High-Value: biologics and small molecules, global drug development, lifecycle management, regulatory agency interactions, remote work, with occasional travel (~10%).