Vice President of Regulatory Affairs in Oncology

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan that is dedicated to addressing patient needs across various fields, including oncology, urology, women's health, rare diseases, and more. We are on the lookout for an accomplished and passionate leader to join our team as the Vice President of Regulatory Affairs in Oncology. This role is ideal for candidates with extensive experience in oncology regulatory affairs, particularly those with a proven track record in recent NDA submissions and global regulatory interactions. As the Vice President, you will be the cornerstone of our regulatory strategy, overseeing non-clinical and clinical submissions, guiding FDA communications, and managing international submissions. Your expertise will be crucial in ensuring compliance and regulatory excellence across both our new and established oncology programs. Key Responsibilities: Partner strategically with other executives to align on regulatory strategies. Lead the Commercial Regulatory Affairs function, acting as an expert on FDA regulations and advertising guidelines for prescription drugs. Guide regulatory interactions with agencies and lead key communications. Provide leadership to marketing and clinical teams, ensuring alignment with regulatory goals and compliance. Oversee development and implementation of advertising and promotion policies. Monitor compliance and minimize risks within R&D activities, particularly concerning regulatory affairs. Set standards for timely reporting on regulatory activities and communicate with leadership. Review regulatory documents at CROs to ensure quality and integrity in submissions. Collaborate with cross-functional teams to assess clinical evidence supporting promotional claims. Offer regulatory leadership for the review of promotional materials, ensuring adherence to regulations and policies. Serve as the regulatory liaison for compliance in medical communications and interactions. Ensure timely submission of all approved promotional materials and compliance with health authority regulations. Oversee the commercial regulatory team's responsibilities, including recruitment, development, and mentorship. Drive 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 biopharmaceutical experience, including at least 10 years in Regulatory Affairs specifically within oncology. Demonstrated experience in strategizing and submitting applications for drug and biologic products. NDA experience in oncology is mandatory. Strong leadership skills with experience in managing a functional team. Robust knowledge of global regulations and guidelines. In return, we offer a competitive salary range between $280,560 and $350,700, complemented by a comprehensive benefits package that includes a merit-based incentive plan, 401(k) contributions, health insurance, and generous paid time off including holidays and sick leave. Join us as we strive to innovate and improve healthcare for patients worldwide. Sumitomo Pharma America (SMPA) is committed to being an Equal Employment Opportunity employer. We encourage diverse candidates to apply without regard to any characteristics protected by law.

Created: 2026-03-12