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 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
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 GRT, lead regulatory activities for assigned project(s) in line with the global registration strategy; represent GRA on project team meetings; lead and coordinate 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 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; review nonclinical, clinical and CMC documentation and contribute content; advise team members on major regulatory issues and mitigation strategies; lead and coordinate local project team members in developing strategy; ensure the quality and content of all submissions to Health Authorities; lead regional health authority meetings and liaison with local Health Authority; document owner of briefing book documentation to Health Authorities; assist with development of the global regulatory functional plan; develop and maintain the development core data sheet (DCDS) if required; ensure compliance with global regulatory requirements and internal policies; provide strategic review of dossier summaries and development management plans; provide updates to GRT and governance boards; lead the Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions; may create/review SOPs and regulatory department operating procedures. Core Competencies: Strong verbal and written communication, ethics and integrity, ability to work in a diverse and matrix environment, adaptability, team decision facilitation, urgency and perseverance, experience with electronic regulatory submissions, advanced medical terminology knowledge, FDA/ICH regulations, ability to review regulatory content, negotiation skills, regulatory strategy development, cross-therapy adaptability, post-marketing/brand awareness, interaction with FDA and ex-US Health Authorities, leadership in Health Authority negotiations and meetings, complex decision making, and executive-level presentation ability. Qualifications
Bachelor’s degree in a related field required. 8–12 years plus a Master’s degree in biotech/pharma regulatory affairs; minimum 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Education and Experience
The base salary range for this role is $187,520 to $234,400. 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 in line with the work state. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off for a year-end shutdown, and sick time. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not intended to be an exhaustive list of responsibilities. All personnel may be required to perform duties outside of their normal responsibilities as needed. Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory, legal and operational rules and procedures for SMPA and affiliates. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Mental/Physical Requirements : Fast paced environment with multiple demands; high initiative and independence; excellent written and oral communication skills; ability to use a PC for extended periods. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics as defined by law. Sumitomo Pharma Co., Ltd. information and links to website and LinkedIn are provided for reference. Our Mission and Vision statements: to broadly contribute to society through innovative R&D for healthcare and to pursue Longer and Healthier Lives with cutting edge technology and ideas.
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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 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
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 GRT, lead regulatory activities for assigned project(s) in line with the global registration strategy; represent GRA on project team meetings; lead and coordinate 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 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; review nonclinical, clinical and CMC documentation and contribute content; advise team members on major regulatory issues and mitigation strategies; lead and coordinate local project team members in developing strategy; ensure the quality and content of all submissions to Health Authorities; lead regional health authority meetings and liaison with local Health Authority; document owner of briefing book documentation to Health Authorities; assist with development of the global regulatory functional plan; develop and maintain the development core data sheet (DCDS) if required; ensure compliance with global regulatory requirements and internal policies; provide strategic review of dossier summaries and development management plans; provide updates to GRT and governance boards; lead the Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions; may create/review SOPs and regulatory department operating procedures. Core Competencies: Strong verbal and written communication, ethics and integrity, ability to work in a diverse and matrix environment, adaptability, team decision facilitation, urgency and perseverance, experience with electronic regulatory submissions, advanced medical terminology knowledge, FDA/ICH regulations, ability to review regulatory content, negotiation skills, regulatory strategy development, cross-therapy adaptability, post-marketing/brand awareness, interaction with FDA and ex-US Health Authorities, leadership in Health Authority negotiations and meetings, complex decision making, and executive-level presentation ability. Qualifications
Bachelor’s degree in a related field required. 8–12 years plus a Master’s degree in biotech/pharma regulatory affairs; minimum 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Education and Experience
The base salary range for this role is $187,520 to $234,400. 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 in line with the work state. Our time-off policy includes flexible paid time off, 11 paid holidays, additional time off for a year-end shutdown, and sick time. Total compensation will depend on candidate experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work and are not intended to be an exhaustive list of responsibilities. All personnel may be required to perform duties outside of their normal responsibilities as needed. Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory, legal and operational rules and procedures for SMPA and affiliates. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Mental/Physical Requirements : Fast paced environment with multiple demands; high initiative and independence; excellent written and oral communication skills; ability to use a PC for extended periods. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics as defined by law. Sumitomo Pharma Co., Ltd. information and links to website and LinkedIn are provided for reference. Our Mission and Vision statements: to broadly contribute to society through innovative R&D for healthcare and to pursue Longer and Healthier Lives with cutting edge technology and ideas.
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