Head of Regulatory Affairs, Oncology

Head of Regulatory Affairs, Oncology

About the Company

Clinical-stage biotech advancing innovative oncology therapies in stealth mode.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is seeking a Head of Regulatory Affairs with a focus on oncology. This pivotal role involves leading the global regulatory strategy for clinical-stage oncology programs, from Phase I to III, and serving as the primary liaison with FDA and other global health authorities. The successful candidate will be responsible for driving INDs, submissions, and regulatory milestones, as well as building and scaling the regulatory function within the organization. This is a hands-on position that requires the ability to operate both strategically and tactically, particularly in a lean environment, and demands a strong track record of FDA interaction and regulatory strategy ownership. The ideal candidate for the Head of Regulatory Affairs position at the company will have a proven background in regulatory leadership within the oncology field, with a preference for those with experience in hematology. The role offers the opportunity to work closely with executive leadership, making it essential for the candidate to have executive presence and strong cross-functional communication skills. The company is in a critical phase of growth, with a clear path toward later-stage development, and the role is instrumental in shaping the regulatory strategy at this pivotal stage. The team is described as lean and collaborative, with a strong scientific foundation, and the role is expected to have a direct impact on the company's trajectory.

Travel Percent
Less than 10%

Functions

• Legal