Director of Regulatory Affairs

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 for8-12+ years of regulatory affairs experience Demonstrated hands-on experience in hematology from a regulatory affairs perspectiveDirect authoring experience across INDs, DSURs, IBs, and clinical protocolsStrong working knowledge of FDA/ICH guidelines and eCTD submission processesExperience managing agency interactions and briefing document developmentBS in life sciences required; MS, PhD, or PharmD preferredComfortable operating in a lean, high-ownership biotech environmentThe 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.