Vice President, Regulatory Affairs - Oncology

Job Overview

We are seeking a dynamic, highly motivated, and experienced leader to serve as the Vice President, Regulatory Affairs Oncology. The candidate must be deeply experienced in Oncology, possess recent Oncology NDA submission experience—including global submissions and HTA interactions—and be capable of supporting all aspects of global commercial product activities. The role will hold accountability for regulatory submissions, regulatory communications, and compliance across the company’s new and established programs.

This position reports to the Chief Medical Officer.

• Strategic thought partner with VP Clinical Development, CMO, and other senior executives.
• Manage the Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion of prescription drugs.
• Guide and/or lead regulatory agency interactions, including communications and meetings.
• Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs, and Clinical Research in the development of advertising and promotion in accordance with business goals, regulations, guidelines, and company policy.
• Manage and support the development and implementation of policies, procedures, and tools related to advertising, promotion, and labeling.
• Manage compliance and risks related to R&D activities, especially regulatory affairs (e.g., SOPs).
• Set clear standards and expectations for accurate and timely reporting of regulatory affairs activity status; provide relevant input to leadership.
• Oversee regulatory activities at CROs, providing document review to ensure the quality and scientific integrity of documents submitted to regulatory authorities.
• Collaborate with Commercial, Medical, and Legal colleagues to review and evaluate clinical evidence supporting proposed claims and assess consistency with FDA-approved labeling.
• Provide regulatory leadership to cross‑functional teams charged with advertising and promotion review to ensure compliance of promotional materials—including Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations, press releases, and external communications—with FDA regulations and company policies.
• Serve as the regulatory member of the Scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical communications, conferences, and ad boards.
• Serve as primary contact leading and facilitating communications with OPDP reviewers for advisory comments and negotiations regarding promotional claims for assigned products, including pre‑clearance of launch materials.
• Direct and ensure the timely submission of all applicable approved promotional materials to the FDA on Form 2253S.
• Ensure compliance of labeling, promotional, and educational materials with governing Health Authorities.
• Manage responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for women’s health and prostate cancer products.
• Recruit, develop, manage, and mentor regulatory professionals and drive a culture of excellence; recognize employees and teams who exceed expectations.
• Provide leadership and direction to clinical regulatory; coach and develop staff, fostering a culture of excellence and high performance.

• Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment.
• Exercise good judgment and make appropriate decisions for the organization.
• Results‑driven; take initiative and ownership to accomplish work.
• Demonstrate flexibility and embrace change in a dynamic, rapidly growing environment.
• Strive for continuous improvement and embrace innovative ideas in daily work.
• Demonstrate coaching skills to inspire, develop, and motivate the team.
• Thought leader with a track record of integrating functional strategies with corporate objectives and translating them into actionable deliverables.
• High degree of organizational awareness; ability to connect interdependencies and the big…