What are the responsibilities and job description for the Director of Regulatory Affairs position at Harris & Co Executive Search?
About the Opportunity:
An immune-oncology biotech company with several novel platforms aimed at overcoming resistance to cancer immunotherapy is seeking a Director of Regulatory Affairs, a hands-on role with capacity for real ownership across IND submissions, DSURs, Investigator's Brochures, and clinical protocols.
What we're looking for
- 8-12 years of regulatory affairs experience
- Demonstrated hands-on experience in hematology from a regulatory affairs perspective
- Direct authoring experience across INDs, DSURs, IBs, and clinical protocols
- Strong working knowledge of FDA/ICH guidelines and eCTD submission processes
- Experience managing agency interactions and briefing document development
- BS in life sciences required; MS, PhD, or PharmD preferred
- Comfortable operating in a lean, high-ownership biotech environment
The position is high impact at a fast moving biotech where your work will directly shape clinical development strategy and report directly into the Head of Regulatory Affairs.
If this aligns with your experience please feel free to get in touch for further information.