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 Title and Purpose
Director Regulatory Affairs
– The Director is part of the Global Regulatory Affairs (GRA) team based in the US. They will primarily function 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 for projects within the portfolio. This role may train/mentor junior staff and works with a high level of autonomy with limited coaching. Job Duties and Responsibilities
Train/mentor junior staff when needed. As a Regional Regulatory Lead, manage regional regulatory activities (United States and/or European) as part of a Global Regulatory Team (GRT). Lead regulatory activities for assigned project(s) in line with the global registration strategy of the product. Represent GRA in project team meetings and coordinate team members to develop strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions; work with Regulatory Operations on electronic submissions. Assess and communicate regulatory requirements to ensure compliance with applicable regulations and guidelines. Document 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) and maintain professional working relationships with colleagues. Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members on regulatory issues and lead mitigation strategies. Lead local project team members in developing strategy for applicable documents/activities. Ensure the quality and content of all submissions to Health Authorities and 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 and maintain the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and 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) 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. Ethics, integrity, and values aligned with SMPA. Ability to work in a diverse environment and adapt to changing priorities in a matrix organization. Ability to facilitate team decisions and demonstrate 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/guidances related to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation and contributing content as needed. Proven success in NDA/MAA/CTD submissions and approvals; ability to negotiate effectively. Development of regulatory strategies and ability to write regulatory strategy documents; ability to learn new therapeutic areas. Experience with post-marketing/brand optimization strategies and commercial awareness; interaction with FDA and ex-US Health Authorities. Experience leading teams and coordinating Health Authority negotiations and meetings; ability to make complex decisions and defend difficult positions. Comfort presenting to all levels of the organization, including Senior Management; strong organizational awareness and ability to see interdependencies. Education and Experience
Bachelor’s degree in a related field required. 8–12 years of relevant experience in biotech or pharmaceutical regulatory affairs; Master’s degree 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 also includes merit-based salary increases, incentive 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, a shutdown period during the last week of December, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education, and other factors. Additional Information
Disclaimer: This description is not exhaustive. All personnel may be required to perform duties outside of normal responsibilities from time to time. EEO statements and compliance information remain in effect.
Confidential Data : All information encountered is confidential.
Compliance : Achieve and maintain compliance with regulatory, legal, and operational rules, ensuring plans and activities for SMPA and affiliates are conducted with best industry practices and high ethical standards. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered without regard to protected characteristics as defined by law.
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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 Title and Purpose
Director Regulatory Affairs
– The Director is part of the Global Regulatory Affairs (GRA) team based in the US. They will primarily function 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 for projects within the portfolio. This role may train/mentor junior staff and works with a high level of autonomy with limited coaching. Job Duties and Responsibilities
Train/mentor junior staff when needed. As a Regional Regulatory Lead, manage regional regulatory activities (United States and/or European) as part of a Global Regulatory Team (GRT). Lead regulatory activities for assigned project(s) in line with the global registration strategy of the product. Represent GRA in project team meetings and coordinate team members to develop strategy for applicable documents/activities. Plan, coordinate, author, and prepare regulatory submissions; work with Regulatory Operations on electronic submissions. Assess and communicate regulatory requirements to ensure compliance with applicable regulations and guidelines. Document 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) and maintain professional working relationships with colleagues. Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members on regulatory issues and lead mitigation strategies. Lead local project team members in developing strategy for applicable documents/activities. Ensure the quality and content of all submissions to Health Authorities and 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 and maintain the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and 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) 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. Ethics, integrity, and values aligned with SMPA. Ability to work in a diverse environment and adapt to changing priorities in a matrix organization. Ability to facilitate team decisions and demonstrate 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/guidances related to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation and contributing content as needed. Proven success in NDA/MAA/CTD submissions and approvals; ability to negotiate effectively. Development of regulatory strategies and ability to write regulatory strategy documents; ability to learn new therapeutic areas. Experience with post-marketing/brand optimization strategies and commercial awareness; interaction with FDA and ex-US Health Authorities. Experience leading teams and coordinating Health Authority negotiations and meetings; ability to make complex decisions and defend difficult positions. Comfort presenting to all levels of the organization, including Senior Management; strong organizational awareness and ability to see interdependencies. Education and Experience
Bachelor’s degree in a related field required. 8–12 years of relevant experience in biotech or pharmaceutical regulatory affairs; Master’s degree 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 also includes merit-based salary increases, incentive 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, a shutdown period during the last week of December, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education, and other factors. Additional Information
Disclaimer: This description is not exhaustive. All personnel may be required to perform duties outside of normal responsibilities from time to time. EEO statements and compliance information remain in effect.
Confidential Data : All information encountered is confidential.
Compliance : Achieve and maintain compliance with regulatory, legal, and operational rules, ensuring plans and activities for SMPA and affiliates are conducted with best industry practices and high ethical standards. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will be considered without regard to protected characteristics as defined by law.
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