Associate Director, RA-CMC PAC DM

Role: Regulatory Affairs - Chemistry, Manufacturing, and Controls (RA-CMC) project manager overseeing post-approval change activities for marketed pharmaceutical products. Key responsibilities include independently managing and compiling CMC sections of variation dossiers, developing content plans and timelines, coordinating with cross-functional teams to ensure submission readiness, and leading global change programs. The position requires ensuring compliance with CTD standards, addressing technical and regulatory content gaps, and supporting other regulatory documentation such as annual reports and renewals. Responsibilities emphasize leadership in project coordination, team mentorship, and process improvement.

Qualifications: Minimum BA/BS in Chemical, Biological Sciences, or related field; 8+ years of pharmaceutical industry experience, with preferred 10+ years including 5+ in regulatory affairs or R&D/manufacturing; experience in CMC dossier preparation and electronic submissions; strong knowledge of manufacturing operations and CTD structure; excellent communication skills; and experience with electronic document management systems. Leadership or supervisory experience of 2+ years is preferred.

High-Value: Focus on post-approval lifecycle management, global regulatory compliance, CMC dossier development, and cross-functional collaboration within biopharma manufacturing and regulatory environments. The role involves technical oversight of marketed products, requiring understanding of manufacturing processes, regulatory standards, and international submission requirements.