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 (LinkedIn URL).
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. Job Duties and Responsibilities
Responsibilities include but are not limited to the following: Train/mentor junior staff (where applicable). As a Regional Regulatory Lead, manage regional regulatory activities (United States and/or European) 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 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; work closely with Regulatory Operations in electronic submissions. Assess and communicate regulatory requirements ensuring activities comply 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 effectively with regulatory operations leader (ROL). Maintain professional working relationships with colleagues, 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 provide possible solutions; 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 liaison with local Health Authorities; document ownership of briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan through research and interpretation of related product approvals and regulatory guidance to support successful submissions and labeling. Develop and maintain the development core data sheet (DCDS) if required; coordinate regulatory compliance activities at a global level. 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 the 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, interpersonal, listening, and organizational skills. Unquestionable ethics, professional integrity, and personal values aligned 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; 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 related to clinical research and general product development. Experience reviewing nonclinical, clinical and CMC documentation and contributing content as needed. Ability to analyze data from multiple sources, draw conclusions, and define actions. Proven involvement in NDA/MAA/CTD submissions and approvals. Strong negotiation skills and ability to defend difficult positions. Development and preparation of successful regulatory strategies and the ability to contribute to a regulatory strategy document. Ability to learn new therapeutic areas when necessary; experience with post-marketing/brand optimization strategies and commercial awareness. Experience interacting with the FDA and international Health Authorities; experience leading teams in Health Authority negotiations and meetings. Ability to make complex decisions and present to Senior Management. High degree of organizational awareness and understanding of interdependencies and the big picture. Education and Experience
Bachelor’s degree in a related field required. 8–12 years with Master’s of relevant experience in biotech or pharmaceutical industry, with minimum 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). 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 provided in line with your work state. Our time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a year-end shutdown, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work performed by people assigned to this classification and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with regulatory, legal, and operational rules and procedures by ensuring plans and activities for SMPA and affiliates are carried out with best industry practices and the highest ethical standards. Mental/Physical Requirements: Fast-paced environment with multiple demands. Requires initiative and independence. Excellent written and oral communication skills. Requires ability to use a PC for extended periods. 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 status, sex, gender, sexual orientation, disability, veteran or military status, or other protected characteristics as required 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 (LinkedIn URL).
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. Job Duties and Responsibilities
Responsibilities include but are not limited to the following: Train/mentor junior staff (where applicable). As a Regional Regulatory Lead, manage regional regulatory activities (United States and/or European) 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 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; work closely with Regulatory Operations in electronic submissions. Assess and communicate regulatory requirements ensuring activities comply 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 effectively with regulatory operations leader (ROL). Maintain professional working relationships with colleagues, 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 provide possible solutions; 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 liaison with local Health Authorities; document ownership of briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan through research and interpretation of related product approvals and regulatory guidance to support successful submissions and labeling. Develop and maintain the development core data sheet (DCDS) if required; coordinate regulatory compliance activities at a global level. 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 the 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, interpersonal, listening, and organizational skills. Unquestionable ethics, professional integrity, and personal values aligned 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; 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 related to clinical research and general product development. Experience reviewing nonclinical, clinical and CMC documentation and contributing content as needed. Ability to analyze data from multiple sources, draw conclusions, and define actions. Proven involvement in NDA/MAA/CTD submissions and approvals. Strong negotiation skills and ability to defend difficult positions. Development and preparation of successful regulatory strategies and the ability to contribute to a regulatory strategy document. Ability to learn new therapeutic areas when necessary; experience with post-marketing/brand optimization strategies and commercial awareness. Experience interacting with the FDA and international Health Authorities; experience leading teams in Health Authority negotiations and meetings. Ability to make complex decisions and present to Senior Management. High degree of organizational awareness and understanding of interdependencies and the big picture. Education and Experience
Bachelor’s degree in a related field required. 8–12 years with Master’s of relevant experience in biotech or pharmaceutical industry, with minimum 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). 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 provided in line with your work state. Our time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a year-end shutdown, and 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on experience, skills, education, and other factors permitted by law. Disclaimer: The above statements describe the general nature and level of work performed by people assigned to this classification and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information encountered is considered confidential. Compliance: Achieve and maintain compliance with regulatory, legal, and operational rules and procedures by ensuring plans and activities for SMPA and affiliates are carried out with best industry practices and the highest ethical standards. Mental/Physical Requirements: Fast-paced environment with multiple demands. Requires initiative and independence. Excellent written and oral communication skills. Requires ability to use a PC for extended periods. 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 status, sex, gender, sexual orientation, disability, veteran or military status, or other protected characteristics as required by law.
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