Our client is a biotechnology company focused on developing novel immunotherapies for cancer. They have asked us to assist them in their search for a Vice President Regulatory Affairs.

Major tasks and responsibilities include:

• Lead and execute regulatory strategy across all programs, partnering cross functionally with preclinical, clinical, CMC, manufacturing quality, and executive leadership.
• Serve as the company’s senior regulatory voice in FDA and other health authorities as needed.
• Provide oversight in the preparation and submission of regulatory filings including INDs, NDAs, CTAs, etc.
• Manage designation strategy (RMAT, BTD, ODD, PRIME, etc.)
• Support transition from early-stage to pivotal development and eventual commercial readiness.
• Evaluate and manage regulatory risks, including establishing regulatory infrastructure, processes, procedures, and systems to ensure compliance with regulatory requirements.
• Build and mentor a high-performing regulatory team aligned with company growth.

We seek candidates with the following qualifications:

• Advanced degree (PhD, MD, or equivalent) with extensive biotech/pharma experience in Regulatory Affairs.
• Strong preference for cell therapy drug development or oncology drug development experience.
• Demonstrated depth in CMC regulatory strategy and filings within cell or gene therapy.
• Prior experience leading the preparation and submission of regulatory filings including INDs, NDAs, CTAs, etc.
• Experience supporting or leading pivotal-stage programs.
• Proven success interacting with FDA and navigating complex regulatory pathways.
• Track record of building and scaling regulatory infrastructure in a growing biotech.
• Possess superior leadership and communication skills and experience in working with multiple functional areas in a fast-paced, matrixed team environment

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.