Associate Director – Regional CMC Liaison

About the role

The Associate Director – Regional CMC Liaison connects global Regulatory CMC teams with local affiliates, ensuring alignment and efficiency in post‑approval submissions across a diverse portfolio of small molecules and biologics. This senior position translates global CMC strategies into actionable regional plans and supports the development of submission packages with a regionalized approach.

Key responsibilities

• Serve as the primary contact between global Regulatory CMC and local affiliates for preparation and delivery of submission packages.
• Translate global CMC strategies into regional plans, ensuring compliance with country‑specific requirements.
• Lead or support regional strategy development, training, and capability‑building initiatives.
• Oversee preparation, review, and submission of regulatory dossiers across the region.
• Identify and implement harmonization opportunities to streamline processes and reduce duplication.
• Build strong relationships with affiliates to understand regulatory needs and challenges.
• Provide regional insights and feedback to global CMC teams.
• Detect bottlenecks in the submission process and propose innovative efficiency solutions.
• Monitor and report on submission timelines and regulatory approvals.

Required profile

• BS/BA in a scientific discipline; advanced degree (M.S., Ph.D.) preferred.
• 10+ years of biopharmaceutical/device industry experience, including 5+ years in pharmaceutical Regulatory CMC or Device roles.
• Experience leading major variations/amendments, IND/IMPD preparation, or NDA/BLA submissions.
• Strong understanding of scientific principles and global HA regulatory requirements beyond EU/US.
• Proven ability to develop and communicate regulatory strategies to cross‑functional teams.

Required skills

• Regulatory CMC expertise