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.

Job Overview

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 with submissions worldwide including HTA submissions. The individual will be responsible for leading the 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. The role will support all aspects of global commercial product. The candidate will be accountable for regulatory submissions, applicable communications, and compliance across the company's new and established programs. This position reports to the Chief Medical Officer.

Job Duties and Responsibilities

• Strategic thought partner with, and provide input to, senior leaders including VP Clinical Development and the 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 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 / 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 regulatory activities at CROs, providing document review to ensure quality and scientific integrity of documents submitted to regulatory authorities
• Collaborate with Commercial, Medical and Legal colleagues to review and evaluate the adequacy of clinical evidence for 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 with FDA regulations and company policies
• Serve as regulatory member of the medical review committee (sMRC) to ensure regulatory compliance for medical communications, congresses, and ad boards
• Lead communications with OPDP reviewers regarding advisory comments and interactions for promotional claims, including pre-clearance of launch materials
• Direct and ensure timely submission of all applicable approved promotional materials to the FDA on Form 2253s
• Ensure labeling, promotional and educational materials comply with governing Health Authorities
• Manage responsibilities for direct reports within the commercial regulatory team for product promotional review and submissions to FDA for women's health and prostate cancer products
• Recruit, develop, manage and mentor regulatory professionals and drive a culture of excellence; reward initiatives that advance business goals
• Provide leadership to clinical regulatory, coach and develop staff, and promote a culture of excellence

Key Core Competencies

Education and Experience

Compensation and Benefits

The base salary range for this role is $280,560 to $350,700. Base salary is part of our total rewards package including merit-based salary increases, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves. Time-off includes flexible paid time off, 11 paid holidays, and additional time off during a year-end shutdown; 80 hours of paid sick time per year. Total compensation depends on candidate experience and other factors permitted by law.

Disclaimer : This description outlines the general nature and level of work and is not an exhaustive list of duties. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

Compliance : Achieve and maintain compliance with applicable regulatory, legal and operational rules and procedures; ensure plans and activities for SMPA and affiliates are carried out with best industry practices and ethics.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered for employment without regard to protected characteristics as defined by law.

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with operations in the U.S., Canada and Europe, focused on oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information, visit our website : SMPA

Mission : To broadly contribute to society through value creation based on innovative R&D activities for better healthcare worldwide.

Vision : For Longer and Healthier Lives, we unlock the future with cutting-edge technology and ideas.

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