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.

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 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.

Job Duties and Responsibilities

• 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 their highest ability

Key Core Competencies

Education and Experience

The base salary range for this role is $280,560 to $350,700. Base salary is part of our total rewards package which includes merit-based salary increases, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves in line with your work state. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off during a year-end shutdown, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education and other factors permitted by law.

Disclaimer : The above statements describe the general nature and level of work and are not to be construed as an exhaustive list of responsibilities. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

Confidential Data : All information that an employee encounters is considered confidential.

Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures to ensure best industry practices and ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may lead to penalties and liability.

Mental / Physical Requirements : Fast-paced environment with multiple demands. Must exercise judgment, have initiative and independence. Excellent written and oral communication skills. Ability to use a computer for extended periods.

SMPA is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to protected characteristics as defined by law.

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