Head of Regulatory Affairs

Head of Regulatory Affairs - Biotech (Oncology / Metabolic)

We are working with a an exciting biotech company awith multiple late-stage programs progressing toward their first NDA filing, this is a high-impact leadership opportunity to establish and scale the global regulatory function at a critical stage of growth.

The Head of Regulatory Affairs will set and drive end-to-end regulatory strategy.

This role will be central in shaping global regulatory pathways, leading key interactions with health authorities, and ensuring high-quality IND and NDA submissions across the US, EU, and other major global markets.

Key Responsibilities:

• Lead preparation and execution of IND, NDA, and global submissions across FDA and EMA
• Serve as the primary interface with health authorities, including FDA meetings (Type B, pre-NDA, and other key engagements)
• Drive late-stage regulatory strategy and NDA readiness activities, including submission planning, coordination, and execution
• Oversee development, review, and submission of regulatory documentation
• Build, develop, and lead the regulatory affairs organization, including internal capability building and external partner oversight
• Strategic input to executive leadership on risks, timelines, and opportunities impacting development and commercialization

Qualifications:

• Bachelors
• 9+ years of Regulatory Affairs experience
• Oncology and/or Metabolic disease
• Leadership experience in regulatory affairs within biotech or pharmaceutical environments
• Experience IND and NDA/BLA submissions
• Deep experience working with FDA, with additional exposure to EMA and other global regulatory authorities
• Strong background in late-stage development and global regulatory strategy
• Success leading health authority interactions and shaping regulatory outcomes