Associate Director – Site CMC

About the role

The Associate Director – Site CMC will lead the efficient and compliant management of regulatory change control and post‑approval activities across multiple manufacturing sites, including external partners. The role applies ICH Q12 principles and drives automation to improve predictability and scalability of regulatory processes.

Key responsibilities

• Lead site‑specific post‑approval change management, including record evaluations and regulatory submissions.
• Apply science‑ and risk‑based approaches guided by ICH Q12 to assess and implement changes.
• Standardize processes and tools to enhance predictability, scalability, and sustainability.
• Explore and implement automation technologies and digital tools for change control and submissions.
• Provide centralized regulatory support for multiple sites covering small molecules and biologics.
• Collaborate with external manufacturing sites and suppliers to align processes with global regulatory expectations.
• Ensure site compliance by evaluating and prioritizing changes based on risk and scientific rationale.
• Facilitate alignment between site teams and global Regulatory CMC on post‑approval strategies.

Required profile

• BS/BA in a scientific discipline; advanced degree (M.S., Ph.D.) preferred.
• 10+ years of biopharmaceutical/device industry experience.
• 5+ years in pharmaceutical Regulatory CMC or Device regulatory roles.
• Experience leading major variations/amendments and supporting IND/IMPD, NDA/BLA submissions.

Required skills

• ICH Q12 principles
• Regulatory change control
• Post‑approval change management
• Automation tools for regulatory processes
• Digital workflow platforms