Director Regional CMC Liaison

About the role

The Director Regional CMC Liaison connects Freyr's global Regulatory CMC teams with local affiliates, ensuring alignment and efficiency for post‑approval submissions across the assigned region. You will translate global strategies into regional plans, support a diverse portfolio of small molecules and biologics, and drive consistency in regulatory dossiers.

Key responsibilities

• Serve as the primary contact between global CMC and local affiliates for preparation and delivery of submission packages.
• Convert global CMC strategies into actionable regional plans that meet country‑specific requirements.
• Oversee preparation, review, and submission of regulatory dossiers throughout the region.
• Develop and implement regional submission strategies to streamline processes and reduce duplication.
• Identify harmonisation opportunities and build strong relationships with affiliates.
• Provide regional insights to global teams and propose solutions to bottlenecks.
• Monitor timelines, report on approvals, and support training and capability‑building initiatives.

Required profile

• BS/BA in a scientific discipline; advanced degree (M.S., Ph.D.) preferred.
• 10+ years in biopharmaceutical or device industry, with at least 8 years in regulatory CMC or related functions.
• Experience leading major variations/amendments, IND/IMPD, NDA/BLA submissions.
• Strong understanding of scientific principles and global CMC regulatory requirements.
• Familiarity with global health authority requirements beyond the EU/US.

Required skills