Sumitomo Pharma
Director, Regulatory Affairs
Sumitomo Pharma, Providence, Rhode Island, us, 02912
Sumitomo Pharma Director, Regulatory Affairs Providence, Rhode Island Apply Now
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. 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 is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. Job Duties and Responsibilities Manage and develop talent, including training/mentoring junior staff. Manage regional (United States and/or European) regulatory activities 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 on project team meetings. Plan, coordinate, author, and prepare regulatory submissions. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Lead documentation of regulatory authority interactions including decisions and outcomes. Provide updates at the Global Regulatory Team meetings and project teams as needed. Collaborate effectively with regulatory operations leader (ROL). Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions. Ensure the quality and content of all submissions to Health Authorities. Lead local project team members in developing strategy for applicable documents/activities. Assist with the development of the global regulatory functional plan. Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. Provide strategic review of dossier summaries, expert statements, and development management plans. Lead Global Regulatory Team (GRT), overseeing planning and execution of global regulatory activities and submissions. Key Core Competencies Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required. Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology, FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry. Proven success/major involvement in NDA/MAA/CTD submissions and approval. High degree of organizational awareness and ability to connect the dots to understand interdependencies and the big picture. Education and Experience 8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer .
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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. 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 is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. Job Duties and Responsibilities Manage and develop talent, including training/mentoring junior staff. Manage regional (United States and/or European) regulatory activities 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 on project team meetings. Plan, coordinate, author, and prepare regulatory submissions. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Lead documentation of regulatory authority interactions including decisions and outcomes. Provide updates at the Global Regulatory Team meetings and project teams as needed. Collaborate effectively with regulatory operations leader (ROL). Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions. Ensure the quality and content of all submissions to Health Authorities. Lead local project team members in developing strategy for applicable documents/activities. Assist with the development of the global regulatory functional plan. Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. Provide strategic review of dossier summaries, expert statements, and development management plans. Lead Global Regulatory Team (GRT), overseeing planning and execution of global regulatory activities and submissions. Key Core Competencies Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required. Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology, FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry. Proven success/major involvement in NDA/MAA/CTD submissions and approval. High degree of organizational awareness and ability to connect the dots to understand interdependencies and the big picture. Education and Experience 8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer .
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