Sumitomo Pharma
Vice President, Regulatory Affairs – Oncology
Sumitomo Pharma, Lansing, Michigan, United States, 48900
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 https://www.us.sumitomo-pharma.com. 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 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 reporting of status of all regulatory affairs activities; provide relevant input to Leadership Oversee the regulatory activities at CROs, providing document review to ensure 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 with FDA-approved labeling Provide regulatory leadership to cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials 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 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, coaching and development and drive a culture of excellence 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 decisions 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 High degree of organizational awareness and ability to understand interdependencies 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, including 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 with the ability to address major strategic challenges and 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 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 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 will depend on 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. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. An employer who violates this law shall be subject to penalties. Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment. Requires a high level of initiative and independence. Excellent written and oral communication skills. Requires ability to use a computer for extended periods. 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 or civil union status, sex, gender, disability, veteran or military status, or any other characteristic protected by law. About Sumitomo Pharma
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key 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 https://www.us.sumitomo-pharma.com.
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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. 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 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 reporting of status of all regulatory affairs activities; provide relevant input to Leadership Oversee the regulatory activities at CROs, providing document review to ensure 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 with FDA-approved labeling Provide regulatory leadership to cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials 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 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, coaching and development and drive a culture of excellence 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 decisions 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 High degree of organizational awareness and ability to understand interdependencies 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, including 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 with the ability to address major strategic challenges and 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 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 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 will depend on 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. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. 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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. An employer who violates this law shall be subject to penalties. Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment. Requires a high level of initiative and independence. Excellent written and oral communication skills. Requires ability to use a computer for extended periods. 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 or civil union status, sex, gender, disability, veteran or military status, or any other characteristic protected by law. About Sumitomo Pharma
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key 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 https://www.us.sumitomo-pharma.com.
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