Vice President, Regulatory Affairs - Oncology

Sumitomo Pharma America, Inc. • Marlborough, MA

108d • $280,560 - $350,700

About The Position

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. 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. This position reports to the Chief Medical Officer.

Requirements

• Advanced degree in a relevant scientific discipline required
• Doctoral degree (MD, PharmD, or PhD) preferred
• 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs in Oncology
• Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs)
• NDA Experience in Oncology required
• Demonstrated leadership skill leading a functional team
• Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional)
• Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges

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 in order 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 the respective cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance 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 the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of 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 both product promotional review and product promotion submissions to FDA for both women’s health and prostate cancer
• Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability
• Provide leadership and direction to clinical regulatory
• Provide coaching and development and drive a culture of excellence that motivates employees to perform at their highest ability

Benefits

• Base salary range of $280,560 to $350,700
• Opportunity for merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life and disability insurances
• Flexible paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree