Head of Regulatory Affairs Oncology

About the Company

Expanding oncology company

Industry
Hospital & Health Care

Type
Public Company

About the Role

The Company is seeking a Head of Regulatory Affairs with a focus on Oncology. This key leadership role involves providing regulatory expertise and guidance to ensure the company's objectives are met. The successful candidate will be responsible for global strategic and operational planning of regulatory activities, building and managing relationships with internal and external stakeholders, and defining strategies for regulatory submissions. The role also includes serving as the primary liaison to global health authorities, such as the US FDA and EMA, and overseeing the preparation of Health Authority meetings. A Bachelor's degree in a scientific discipline is required, with an advanced degree being a plus, and a minimum of 10 years of experience in a pharmaceutical or biotechnology organization, including significant time in a Regulatory Affairs leadership position. Applicants must have a proven track record of success in gaining regulatory approvals and in-depth knowledge of regulatory guidelines, particularly in the US and EU. Oncology experience is a mandatory requirement, and experience in regulatory CMC and CDx is preferred. The ideal candidate will have experience with INDs, NDAs, CTAs, and post-marketing activities such as variations, renewals, and labeling. The role also involves managing, coaching, and mentoring a team of direct reports. The position is remote on the East Coast, with the expectation of travel to New Jersey 1-3 times per month.

Travel Percent
Less than 10%

Functions

• General Management