Sumitomo Pharma
Overview
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. The company aims to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job overview: We are seeking a dynamic, highly motivated and experienced individual for the position of
Director Regulatory Affairs . The Director Regulatory Affairs is part of the Global Regulatory Affairs (GRA) team based in the US and will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This role leads the development and implementation of regulatory strategy from proof of concept through development, registration, and post-approval for projects within the portfolio. The position 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 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 closely with Regulatory Operations in electronic submission. Assess and communicate regulatory requirements to ensure 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 effectively with regulatory operations leader (ROL). Maintain professional working relationships with colleagues to foster 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 developing strategy 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. Document owner of briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan and support successful submission and target product labeling. Accountable for developing and maintaining the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and coordinate global regulatory compliance activities. 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. Key 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 and adapt to changing priorities in a matrix organization. Ability to facilitate appropriate team decisions and demonstrate 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/guidances related to clinical research and product development in the pharmaceutical industry. Experience reviewing nonclinical, clinical and CMC documentation and contributing to content as needed. Ability to assess issues and opportunities by comparing data from different sources to determine action. Proven success or major involvement in NDA/MAA/CTD submissions and approvals. Strong negotiation skills with the ability to maintain composure. Development and preparation of regulatory strategies and ability to contribute to strategy documents. Ability to learn new therapeutic areas when necessary and experience with post-marketing/brand optimization strategies and commercial awareness. Experience interacting 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 difficult positions; comfortable presenting to all organizational levels including senior management. High degree of organizational awareness and ability to understand interdependencies. Education and Experience
Bachelor’s degree in a related field required. 8–12 years with a Master’s of relevant experience in biotech or pharmaceutical industry, with a minimum of 8 years in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Compensation and Other Details
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) plan, medical/dental/vision/life and disability insurances, and leaves in line with state. Time-off policy includes flexible paid time off, 11 paid holidays, December shutdown leave, 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. Disclaimer: The above outlines general responsibilities and duties and is not exhaustive. 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. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, sex, disability, veteran or military status, or any other characteristic protected by law.
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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. The company aims to accelerate discovery, research, and development to bring novel therapies to patients sooner. Job overview: We are seeking a dynamic, highly motivated and experienced individual for the position of
Director Regulatory Affairs . The Director Regulatory Affairs is part of the Global Regulatory Affairs (GRA) team based in the US and will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This role leads the development and implementation of regulatory strategy from proof of concept through development, registration, and post-approval for projects within the portfolio. The position 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 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 closely with Regulatory Operations in electronic submission. Assess and communicate regulatory requirements to ensure 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 effectively with regulatory operations leader (ROL). Maintain professional working relationships with colleagues to foster 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 developing strategy 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. Document owner of briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan and support successful submission and target product labeling. Accountable for developing and maintaining the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and coordinate global regulatory compliance activities. 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. Key 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 and adapt to changing priorities in a matrix organization. Ability to facilitate appropriate team decisions and demonstrate 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/guidances related to clinical research and product development in the pharmaceutical industry. Experience reviewing nonclinical, clinical and CMC documentation and contributing to content as needed. Ability to assess issues and opportunities by comparing data from different sources to determine action. Proven success or major involvement in NDA/MAA/CTD submissions and approvals. Strong negotiation skills with the ability to maintain composure. Development and preparation of regulatory strategies and ability to contribute to strategy documents. Ability to learn new therapeutic areas when necessary and experience with post-marketing/brand optimization strategies and commercial awareness. Experience interacting 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 difficult positions; comfortable presenting to all organizational levels including senior management. High degree of organizational awareness and ability to understand interdependencies. Education and Experience
Bachelor’s degree in a related field required. 8–12 years with a Master’s of relevant experience in biotech or pharmaceutical industry, with a minimum of 8 years in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Compensation and Other Details
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) plan, medical/dental/vision/life and disability insurances, and leaves in line with state. Time-off policy includes flexible paid time off, 11 paid holidays, December shutdown leave, 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. Disclaimer: The above outlines general responsibilities and duties and is not exhaustive. 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. Sumitomo Pharma America is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, sex, disability, veteran or military status, or any other characteristic protected by law.
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