Sumitomo Pharma
Director, Regulatory Affairs
Sumitomo Pharma, Montpelier, Vermont, us, 05604
Sumitomo Pharma Director, Regulatory Affairs Montpelier, Vermont Apply Now
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan 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, leading the development and implementation of regulatory strategies from proof of concept through registration and post-approval. 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. Lead regional regulatory activities as part of a Global Regulatory Team (GRT). 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. Document regulatory authority interactions. Collaborate effectively with regulatory operations leaders. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Lead regional health authority meetings and liaise with local Health Authorities. Ensure compliance with global regulatory requirements and internal policies. Provide strategic review of dossier summaries and development management plans. Lead Global Regulatory Team (GRT) in planning and execution of global regulatory activities and submissions. Key Core Competencies Strong verbal and written communication skills. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities. Proven success in NDA/MAA/CTD submissions. Experience interacting with FDA and ex-US Health Authorities. Education and Experience 8 – 12 years in the biotech or pharmaceutical industry with a minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits The base salary range for this role is $183,000 to $228,800, with additional benefits including merit-based salary increases, short incentive plan participation, and a robust time-off policy. Equal Employment Opportunity Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce.
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Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan 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, leading the development and implementation of regulatory strategies from proof of concept through registration and post-approval. 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. Lead regional regulatory activities as part of a Global Regulatory Team (GRT). 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. Document regulatory authority interactions. Collaborate effectively with regulatory operations leaders. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Lead regional health authority meetings and liaise with local Health Authorities. Ensure compliance with global regulatory requirements and internal policies. Provide strategic review of dossier summaries and development management plans. Lead Global Regulatory Team (GRT) in planning and execution of global regulatory activities and submissions. Key Core Competencies Strong verbal and written communication skills. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities. Proven success in NDA/MAA/CTD submissions. Experience interacting with FDA and ex-US Health Authorities. Education and Experience 8 – 12 years in the biotech or pharmaceutical industry with a minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits The base salary range for this role is $183,000 to $228,800, with additional benefits including merit-based salary increases, short incentive plan participation, and a robust time-off policy. Equal Employment Opportunity Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce.
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