Vice President, Regulatory Affairs - Oncology

Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website at the SMPA site.

We are currently seeking a dynamic, highly motivated, and experienced leader for the position of Vice President, Regulatory Affairs Oncology
. The candidate must be deeply experienced in Oncology and have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the candidate must have experience with supporting all aspects of global commercial product.

The role will hold accountability for regulatory submissions, applicable communications, and compliance across the company’s new and established programs.

This position reports to the Chief Medical Officer.

• Strategic thought partner including with but not limited to VP Clin Dev and CMO
• Manage 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 and objectives, regulations, guidelines, and company policy
• Manage and/or 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 activities of regulatory affairs (e.g., SOPs)
• Set clear standards and expectations for the accurate and timely reporting of status of all regulatory affairs activities; provide relevant input to Leadership
• Oversee the regulatory activities at CROs, providing document review to ensure the quality and scientific integrity of documents submitted to regulatory authorities
• In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with FDA-approved labeling
• Provide regulatory leadership to cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials with FDA regulations and Company policies
• Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses, and ad boards
• Serve as primary contact leading and facilitating communications with OPDP reviewers 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
• Managing responsibilities for direct reports within the commercial regulatory team for product promotional review and product promotion submissions to FDA for women’s health and prostate cancer
• Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence
• Provide leadership and direction to clinical regulatory, coaching and development to motivate employees to perform at…