Sumitomo Pharma
Overview
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH). The company focuses on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies, with marketed products and a diverse pipeline to accelerate discovery, research, and development for patients worldwide. Job Overview
We are seeking a dynamic, highly motivated, and experienced individual for the position of
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. The role functions as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position leads the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval within the portfolio. The role may train/mentor junior staff and works with a high level of autonomy with limited coaching. Job Duties and Responsibilities
Manage and Develop Talent May train/mentor junior staff Phases I-IV Research & Development Activities As a Regional Regulatory Lead, manage regional regulatory activities as part of a Global Regulatory Team (GRT) for the United States and/or Europe. As part of the GRT, lead regulatory activities for assigned projects in line with global registration strategy. Represent GRA in project team meetings. Lead and coordinate team members in developing strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions; work with Regulatory Operations in electronic submissions. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Lead documentation of regulatory authority interactions including decisions and outcomes. Provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Maintain professional working relationships, fostering collaboration and idea sharing. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and lead mitigation strategies. Lead and coordinate local project team members in strategy development for applicable documents/activities. Ensure the quality and content of all submissions to Health Authorities. Lead regional health authority meetings and liaise with local Health Authorities; own briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan through research and interpretation of regulatory guidance and recent proceedings to support successful submissions and labeling. Maintain development core data sheet (DCDS) when required, and ensure compliance with global regulatory requirements and internal policies. Provide strategic review of dossier summaries, expert statements, and development management plans; provide updates to GRT, project teams, and governance boards as needed. Lead Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions. May create and review SOPs and regulatory department operating procedures. Key Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills. Unquestionable ethics and professional integrity aligned with SMPA values. Ability to work in a diverse environment and adapt to changing priorities in a matrix organization. Ability to facilitate team decisions and maintain a sense of urgency to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology and FDA/ICH regulations relevant to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation and contributing to content as needed. Ability to analyze data from multiple sources to draw conclusions and determine action. Proven involvement in NDA/MAA/CTD submissions and approvals; strong negotiation skills. Development of regulatory strategies and ability to contribute to regulatory strategy documents; ability to learn new therapeutic areas as needed. Experience with post-marketing/brand strategies and commercial awareness; interaction with the FDA and ex-US Health Authorities. Experience leading teams and providing leadership in Health Authority negotiations and meetings; ability to make complex decisions and defend positions. Comfort presenting to all levels of the organization, including Senior Management; high organizational awareness. Education and Experience
Bachelor’s degree in a related field required. 8–12 years of relevant biotechnology/pharmaceutical experience in regulatory affairs; Master’s preferred. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package, which includes merit-based increases, eligibility for our 401(k) plan, medical/dental/vision/life and disability insurances, and leaves as per state law. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off during a year-end shutdown, and 80 hours of paid sick time on hire and annually thereafter. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Compliance and EEO
Disclaimer: The statements describe general nature of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities from time to 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 or domestic status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada, and Europe, focused on addressing patient needs in oncology, urology, women’s health, rare diseases, psychiatry & nerology, and cell & gene therapies. For more information, visit our website at https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
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Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH). The company focuses on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies, with marketed products and a diverse pipeline to accelerate discovery, research, and development for patients worldwide. Job Overview
We are seeking a dynamic, highly motivated, and experienced individual for the position of
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. The role functions as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position leads the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval within the portfolio. The role may train/mentor junior staff and works with a high level of autonomy with limited coaching. Job Duties and Responsibilities
Manage and Develop Talent May train/mentor junior staff Phases I-IV Research & Development Activities As a Regional Regulatory Lead, manage regional regulatory activities as part of a Global Regulatory Team (GRT) for the United States and/or Europe. As part of the GRT, lead regulatory activities for assigned projects in line with global registration strategy. Represent GRA in project team meetings. Lead and coordinate team members in developing strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions; work with Regulatory Operations in electronic submissions. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Lead documentation of regulatory authority interactions including decisions and outcomes. Provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Maintain professional working relationships, fostering collaboration and idea sharing. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and lead mitigation strategies. Lead and coordinate local project team members in strategy development for applicable documents/activities. Ensure the quality and content of all submissions to Health Authorities. Lead regional health authority meetings and liaise with local Health Authorities; own briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan through research and interpretation of regulatory guidance and recent proceedings to support successful submissions and labeling. Maintain development core data sheet (DCDS) when required, and ensure compliance with global regulatory requirements and internal policies. Provide strategic review of dossier summaries, expert statements, and development management plans; provide updates to GRT, project teams, and governance boards as needed. Lead Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions. May create and review SOPs and regulatory department operating procedures. Key Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills. Unquestionable ethics and professional integrity aligned with SMPA values. Ability to work in a diverse environment and adapt to changing priorities in a matrix organization. Ability to facilitate team decisions and maintain a sense of urgency to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology and FDA/ICH regulations relevant to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation and contributing to content as needed. Ability to analyze data from multiple sources to draw conclusions and determine action. Proven involvement in NDA/MAA/CTD submissions and approvals; strong negotiation skills. Development of regulatory strategies and ability to contribute to regulatory strategy documents; ability to learn new therapeutic areas as needed. Experience with post-marketing/brand strategies and commercial awareness; interaction with the FDA and ex-US Health Authorities. Experience leading teams and providing leadership in Health Authority negotiations and meetings; ability to make complex decisions and defend positions. Comfort presenting to all levels of the organization, including Senior Management; high organizational awareness. Education and Experience
Bachelor’s degree in a related field required. 8–12 years of relevant biotechnology/pharmaceutical experience in regulatory affairs; Master’s preferred. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package, which includes merit-based increases, eligibility for our 401(k) plan, medical/dental/vision/life and disability insurances, and leaves as per state law. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off during a year-end shutdown, and 80 hours of paid sick time on hire and annually thereafter. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Compliance and EEO
Disclaimer: The statements describe general nature of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities from time to 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 or domestic status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with key operations in the U.S., Canada, and Europe, focused on addressing patient needs in oncology, urology, women’s health, rare diseases, psychiatry & nerology, and cell & gene therapies. For more information, visit our website at https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
#J-18808-Ljbffr