Vice President, Regulatory Affairs - Oncology

Vice President, Regulatory Affairs Oncology

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe 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. In addition, the candidate must 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 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.

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 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.

Key Core Competencies

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

Education and Experience

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.

The base salary range for this role is $280,560 to $350,700. Base salary is part of our total rewards package which also includes the 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. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer : The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental / Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.