Vice President, Regulatory Affairs - Oncology

Sumitomo Pharma•Marlborough, MA

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. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn . 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. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual will be responsible for l eading 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 be 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.

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 (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision.
Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
Exercise good judgment and make decision that is appropriate for the organization
Results-driven, take initiative and ownership to accomplish work
Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
Strive for continuous improvement and embrace innovative ideas in daily work
Demonstrate coaching skill to inspire, develop, and motivate team
Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture

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. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals
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. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals.

Benefits

opportunity for merit-based salary increases
short incentive plan participation
eligibility for our 401(k) plan
medical, dental, vision, life and disability insurances and leaves provided in line with your work state
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

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume