Senior Director, Regulatory Affairs Advertising & Promotion

Senior Director, Regulatory Affairs Advertising & Promotion

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world‑class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Our Clinical Studies: Summit has multiple global Phase 3 clinical studies, including non‑small cell lung cancer (NSCLC) programs (HARMONi, HARMONi‑3, HARMONi‑7, HARMONi‑GI3). Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

The Senior Director is responsible for reviewing materials submitted to the Medical Review Committee (MRC) and Summit’s Promotional Review Committee (PRC), ensuring compliance with applicable regulations, guidance documents, and internal policies/SOPs.

Role and Responsibilities

• Accountable for evaluating all perspectives (Commercial, Legal/Compliance, Medical) and providing expert regulatory guidance for promotional, disease state education, corporate, and other non‑promotional materials for relevant products and therapeutic areas.
• Review materials in Veeva and actively participate in MRC and PRC meetings.
• Interpret enforcement actions, stay current with industry changes related to advertising and promotion, and evaluate new FDA guidance documents and internal policies/best practices.
• Contribute to implementing internal MRC/PRC processes to ensure all materials comply with FDA regulations.
• Provide regulatory guidance on overall process enhancements to ensure compliance and process efficiencies.
• Develop and implement regulatory advertising/promotion strategy and manage complex negotiations with internal and external stakeholders.
• Guide communications with HCPs, patients/consumers, payers, executive management, and other audiences.
• Facilitate the submission of branded promotional materials to the FDA on Form 2253.
• Act as the main point of contact with the FDA’s Office of Prescription Drug Promotion.
• Advise management and cross‑functional team members on the effect of current or proposed relevant laws, regulations, guidelines, and standards.
• Ensure corporate goals are met with respect to assigned projects.
• Act independently under direction of Vice President of Regulatory Affairs; expected to represent regulatory with little to no oversight.
• May have direct reports and contribute to performance management for other RA team members.
• May advance the organization’s goals by participating in professional associations, industry, and trade groups as appropriate.
• Follow budget allocations.

Experience, Education and Specialized Knowledge and Skills

• Bachelor’s degree in a scientific discipline and 12+ years of related experience, or equivalent combination of education and experience.
• Advanced degree (MS, PharmD) preferred.
• Strong regulatory advertising/promotion knowledge.
• Demonstrated success in preparation and submission of regulatory documents.
• Strong understanding of the role of advertising/promotion and the regulatory requirements for promotion of prescription drugs.
• Experienced user of the Veeva ecosystem related to review and submission of PRC‑related items.
• Strong communication and proactive negotiation skills.
• Ability to communicate complex ideas understandably.
• Ability to work successfully in a fast‑paced, demanding, and collaborative environment.
• Travel up to approximately 5 %.

Pay Transparency

Salary: $200,000 – $235,000 USD. Actual compensation packages are based on factors unique to each candidate, including skill set, depth of experience, certifications, and work location. The total compensation package may also include bonus, stock, benefits, and/or other variable compensation.

Equal Employment Opportunity Statement: Summit Therapeutics Inc. is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, training, or promotion for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

#J-18808-Ljbffr