Sumitomo Pharma
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. Job Overview We are currently 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. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. Responsibilities
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 (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) As part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product Represent GRA on project team meetings Lead and coordinate project team members in developing strategy for applicable documents/ activities Plan, coordinate, author, and prepare regulatory submissions and work with Regulatory Operations in electronic submissions Assess and communicate regulatory requirements ensuring activities comply 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 with regulatory operations leader (ROL) Maintain professional working relationships with colleagues, fostering collaboration Review nonclinical, clinical and CMC documentation and contribute to content as needed Advise team members of major regulatory issues and provide solutions and mitigation strategies Lead and coordinate local project team members in developing strategy for applicable documents/activities Ensure the quality and content of all submissions to Health Authorities Lead regional health authority meetings and liaison with local Health Authorities Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan through research and interpretation of regulatory guidance to support successful submission and labeling Accountable with the GRL for developing and maintaining the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies; coordinate regulatory compliance activities globally Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to the GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT), oversee planning and execution of global regulatory activities and submissions May be responsible for creating and reviewing SOPs and regulatory department operating procedures Core Competencies
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills Unquestionable ethics, professional integrity, and personal values consistent with SMPA values Ability to work in a diverse environment Demonstrated ability to adapt to changing priorities and work in a matrix organization Demonstrated ability to facilitate appropriate team decisions Sense of urgency and perseverance to achieve results Experience contributing to electronic regulatory submissions and working with regulatory templates Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed Ability to analyze data from different sources to draw conclusions and determine actions Proven success in NDA/MAA/CTD submissions and approvals Negotiation skills with composure Development and preparation of regulatory strategies and writing of strategy documents Ability to learn new therapeutic areas when necessary Experience with post-marketing/brand optimization strategies and commercial awareness Experience interacting with FDA and ex-US Health Authorities Experience leading teams and Health Authority negotiations Ability to make complex decisions and defend difficult positions Comfortable presenting to Senior Management High organizational awareness and ability to see interdependencies Education and Experience
Bachelor’s degree in a related field required 8 – 12 years with Master’s in biotech or pharmaceutical industry with at least 8 years focused in regulatory affairs Master’s degree required (preferably scientific) The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package including merit-based increases, eligibility for our 401(k), medical/dental/vision/life and disability insurances, and leaves in line with state. Our time-off policy includes flexible paid time off, 11 paid holidays, and additional time off during a year-end shutdown. Total compensation will depend on experience, skills, and other factors permitted by law. Disclaimer: The above describes the general nature of work; it is not an exhaustive list of responsibilities. All personnel may be required to perform duties outside of normal responsibilities as needed. Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory, legal and operational rules and procedures, ensuring that plans for SMPA and affiliates are carried out with high ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may incur penalties. Mental/Physical Requirements : Fast-paced environment with multiple demands. Requires initiative, independence, and excellent written and oral communication skills. Requires use of a computer for extended periods. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer Qualified applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or civil union status, sex, gender, sexual orientation, disability, veteran status, or any other protected characteristic. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company 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. With marketed products and a diverse pipeline, we aim to accelerate discovery, research, and development. For more information visit https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
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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 or follow us on LinkedIn. Job Overview We are currently 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. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. Responsibilities
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 (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT) As part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product Represent GRA on project team meetings Lead and coordinate project team members in developing strategy for applicable documents/ activities Plan, coordinate, author, and prepare regulatory submissions and work with Regulatory Operations in electronic submissions Assess and communicate regulatory requirements ensuring activities comply 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 with regulatory operations leader (ROL) Maintain professional working relationships with colleagues, fostering collaboration Review nonclinical, clinical and CMC documentation and contribute to content as needed Advise team members of major regulatory issues and provide solutions and mitigation strategies Lead and coordinate local project team members in developing strategy for applicable documents/activities Ensure the quality and content of all submissions to Health Authorities Lead regional health authority meetings and liaison with local Health Authorities Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan through research and interpretation of regulatory guidance to support successful submission and labeling Accountable with the GRL for developing and maintaining the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies; coordinate regulatory compliance activities globally Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to the GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT), oversee planning and execution of global regulatory activities and submissions May be responsible for creating and reviewing SOPs and regulatory department operating procedures Core Competencies
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills Unquestionable ethics, professional integrity, and personal values consistent with SMPA values Ability to work in a diverse environment Demonstrated ability to adapt to changing priorities and work in a matrix organization Demonstrated ability to facilitate appropriate team decisions Sense of urgency and perseverance to achieve results Experience contributing to electronic regulatory submissions and working with regulatory templates Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed Ability to analyze data from different sources to draw conclusions and determine actions Proven success in NDA/MAA/CTD submissions and approvals Negotiation skills with composure Development and preparation of regulatory strategies and writing of strategy documents Ability to learn new therapeutic areas when necessary Experience with post-marketing/brand optimization strategies and commercial awareness Experience interacting with FDA and ex-US Health Authorities Experience leading teams and Health Authority negotiations Ability to make complex decisions and defend difficult positions Comfortable presenting to Senior Management High organizational awareness and ability to see interdependencies Education and Experience
Bachelor’s degree in a related field required 8 – 12 years with Master’s in biotech or pharmaceutical industry with at least 8 years focused in regulatory affairs Master’s degree required (preferably scientific) The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package including merit-based increases, eligibility for our 401(k), medical/dental/vision/life and disability insurances, and leaves in line with state. Our time-off policy includes flexible paid time off, 11 paid holidays, and additional time off during a year-end shutdown. Total compensation will depend on experience, skills, and other factors permitted by law. Disclaimer: The above describes the general nature of work; it is not an exhaustive list of responsibilities. All personnel may be required to perform duties outside of normal responsibilities as needed. Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory, legal and operational rules and procedures, ensuring that plans for SMPA and affiliates are carried out with high ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may incur penalties. Mental/Physical Requirements : Fast-paced environment with multiple demands. Requires initiative, independence, and excellent written and oral communication skills. Requires use of a computer for extended periods. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer Qualified applicants will be considered without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital or civil union status, sex, gender, sexual orientation, disability, veteran status, or any other protected characteristic. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company 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. With marketed products and a diverse pipeline, we aim to accelerate discovery, research, and development. For more information visit https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
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