Associate Director, Regulatory Affairs – CMC

Associate Director, Regulatory Affairs – CMC, leading global regulatory strategies for small-molecule drug development, registration, and lifecycle management.

Responsibilities include developing and implementing CMC regulatory plans, providing strategic guidance on manufacturing, formulation, and analytical methods, and supporting lifecycle changes and post-approval submissions. The position involves authoring and reviewing regulatory documents, managing global variation filings, and liaising with health authorities such as FDA and EMA.

Requirements:
Bachelor's in Chemistry, Pharmaceutical Sciences, or related; 10+ years in pharmaceutical/regulatory CMC roles with substantial experience supporting marketed small-molecule products; deep knowledge of U.S. and global post-approval CMC regulatory frameworks, including SUPAC, NDAs, amendments, and variations. Preferred: advanced degrees (MS, PharmD, PhD), experience with solid oral dosage forms, and direct interactions with regulatory agencies. High-Value: expertise supporting late-stage clinical or post-market products, global CMC regulations, and lifecycle management.

The role is based remotely with a salary range of $180,000–$195,000, with comprehensive benefits.