Vice President of Oncology Regulatory Affairs

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company dedicated to addressing patient needs across various fields, including oncology, urology, women's health, and rare diseases. We are seeking a dynamic and experienced leader to join our team as the Vice President of Oncology Regulatory Affairs. This position is perfect for candidates who have extensive expertise in oncology regulatory affairs, especially those who have successfully navigated recent NDA submissions and managed global regulatory interactions. In this pivotal role, you will shape our regulatory strategy, oversee non-clinical and clinical submissions, guide FDA communications, and manage international submissions. Your deep knowledge will be instrumental in ensuring compliance and regulatory excellence in both our new and established oncology programs. Key Responsibilities: Collaborate strategically with executives to align on comprehensive regulatory strategies. Lead the Commercial Regulatory Affairs function, providing expertise on FDA regulations and advertising guidelines for prescription drugs. Facilitate regulatory interactions with agencies and lead vital communications. Support marketing and clinical teams by ensuring alignment with regulatory goals and compliance standards. Oversee the development and implementation of advertising and promotion policies. Monitor compliance and mitigate risks in R&D activities related to regulatory affairs. Establish standards for timely reporting on regulatory activities and communicate effectively with leadership. Review regulatory documents from CROs to ensure quality and integrity in submissions. Work with cross-functional teams to evaluate clinical evidence supporting promotional claims. Provide regulatory guidance for the review of promotional materials, ensuring adherence to regulations and internal policies. Act as the regulatory liaison for compliance in medical communications and interactions. Ensure the timely submission of approved promotional materials and compliance with health authority regulations. Supervise the responsibilities of the commercial regulatory team, including recruitment, development, and mentorship. Foster a culture of excellence and continuous improvement within the team. Qualifications: Advanced degree in a relevant scientific discipline is required; a doctoral degree (MD, PharmD, or PhD) is preferred. A minimum of 15 years of experience in the biopharmaceutical industry, with at least 10 years specifically in Regulatory Affairs within oncology. Proven experience strategizing and submitting applications for drug and biologic products. NDA experience in oncology is crucial. Exceptional leadership skills with a track record of managing functional teams. In-depth knowledge of global regulations and guidelines is essential. We offer a competitive salary range of $280,560 to $350,700, along with a comprehensive benefits package that includes a merit-based incentive plan, 401(k) contributions, health insurance, and generous paid time off, inclusive of holidays and sick leave. Join us in our mission to innovate and elevate healthcare for patients worldwide. Sumitomo Pharma America (SMPA) is committed to being an Equal Employment Opportunity employer, welcoming diverse candidates to apply regardless of any characteristics protected by law.

Created: 2026-03-10