Vice President, Regulatory Affairs, Oncology

Vice President, Regulatory Affairs, Oncology

About the Company

Globally-recognized pharmaceutical company

Industry

Pharmaceuticals

Type

Privately Held

Founded

2023

Employees

1001-5000

Funding

$101-$200 million

Categories

• Pharmaceuticals
• Medicine
• Manufacturing
• Chemical Products

About the Role

The Company is seeking a Vice President for Regulatory Affairs in Oncology. The successful candidate will be a strategic thought partner, deeply experienced in oncology, with a focus on leading the development of all non-clinical and clinical regulatory strategies. This includes the management of IND and NDA submissions, global regulatory interactions, and international submissions. The role also involves supporting all aspects of global commercial product regulatory affairs. The VP will be accountable for regulatory submissions, communications, and compliance across the company's new and established programs. Key responsibilities include guiding and leading regulatory agency interactions, providing strategic and operational leadership to cross-functional teams, and ensuring the compliance of promotional materials with FDA regulations and company policies.

Applicants for the Vice President, Regulatory Affairs Oncology position at the company should have an advanced degree in a relevant scientific discipline, with a preference for a doctoral degree. A minimum of 15 years' biopharmaceutical experience, including at least 10 years in regulatory affairs in oncology, is required. The ideal candidate will have a proven track record in preparing and submitting regulatory applications for drug or biologic products, with specific experience in NDA submissions in oncology. Strong leadership skills, comprehensive knowledge of global regulations, and the ability to balance short-term needs with long-term vision are essential. The role demands a results-driven individual with the ability to manage and influence stakeholders effectively, and a commitment to continuous improvement and innovation in a dynamic, rapidly growing environment.

Hiring Manager Title

Chief Medical Officer

Travel Percent

Less than 10%

Functions