Sumitomo Pharma
Vice President, Regulatory Affairs - Oncology
Sumitomo Pharma, Tallahassee, Florida, us, 32318
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 or follow us on LinkedIn (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 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. The candidate must be experienced with supporting all aspects of global commercial product. The role will hold accountability for regulatory submissions, applicable communications, and compliance across the companys new and established programs. This position reports to the Chief Medical Officer. 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 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 Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases 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 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 Own responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for womens health and prostate cancer Recruit, develop, manage and mentor regulatory professionals and drive a culture of excellence; recognize employees and teams who excel in advancing business goals Provide leadership and direction to clinical regulatory; provide 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 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 and translate them into actionable deliverables High degree of organizational awareness and ability to understand interdependencies and the 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 Regulatory Affairs experience 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 addressing major strategic challenges while balancing short-term and long-term goals 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. Our time-off policy includes flexible paid time off, 11 paid holidays plus 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. Disclaimer: The above statements describe the general nature and level of work and are not exhaustive of all responsibilities, duties, and skills required. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data : All information encountered 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. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires initiative, independence, excellent written and verbal communication skills, and 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, domestic partnership or civil union status; sex, gender; sexual orientation; disability; veteran or military status; or any other characteristic protected by law. #J-18808-Ljbffr
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 (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 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. The candidate must be experienced with supporting all aspects of global commercial product. The role will hold accountability for regulatory submissions, applicable communications, and compliance across the companys new and established programs. This position reports to the Chief Medical Officer. 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 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 Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases 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 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 Own responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for womens health and prostate cancer Recruit, develop, manage and mentor regulatory professionals and drive a culture of excellence; recognize employees and teams who excel in advancing business goals Provide leadership and direction to clinical regulatory; provide 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 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 and translate them into actionable deliverables High degree of organizational awareness and ability to understand interdependencies and the 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 Regulatory Affairs experience 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 addressing major strategic challenges while balancing short-term and long-term goals 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. Our time-off policy includes flexible paid time off, 11 paid holidays plus 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. Disclaimer: The above statements describe the general nature and level of work and are not exhaustive of all responsibilities, duties, and skills required. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data : All information encountered 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. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires initiative, independence, excellent written and verbal communication skills, and 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, domestic partnership or civil union status; sex, gender; sexual orientation; disability; veteran or military status; or any other characteristic protected by law. #J-18808-Ljbffr