Head, Regulatory Affairs

The successful candidate brings the rare combination of hands-on Regulatory Operations expertise and strategic Regulatory Affairs leadership

Responsibilities

• Serve as the regulatory lead for interactions with health authorities, including FDA, EMA, and other global agencies
• Lead and oversee Regulatory Operations, ensuring the timely, high-quality planning, publishing, and submission of global regulatory dossiers (INDs, CTAs, NDAs, BLAs, MAAs, and lifecycle submissions).
• Drive regulatory submission strategy and execution, ensuring compliance with global regulatory requirements and electronic submission standards.
• Partner cross-functionally with Clinical, CMC, Quality, Medical Writing, and Project Management to deliver regulatory milestones.

Qualifications

• 12-15+ years of Regulatory Affairs/Regulatory Operations experience within biotechnology or pharmaceuticals.
• Extensive experience managing global regulatory submissions, publishing, and electronic document management systems (eCTD).
• Strong understanding of global regulatory requirements and submission processes across FDA, EMA, and other health authorities.
• Experience supporting or contributing to Regulatory Strategy and cross-functional regulatory planning.
• Rare disease, orphan drug, or specialty biotech experience preferred.