Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Jackson, Mississippi, United States, 39200
Sumitomo Pharma Associate Director, Regulatory Affairs Jackson , Mississippi 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
Associate Director, Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). Job Duties and Responsibilities Manage regional regulatory activities as part of a Global Regulatory Team (GRT). Ensure execution of regional regulatory plans in line with the global registration strategy. Lead preparation, coordination, authoring, and monitoring of submissions (e.g., IND/NDA submissions). Represent GRA on less complex project-related meetings and provide regulatory input. Assess and communicate regulatory requirements ensuring compliance with applicable regulations. Lead the documentation of regulatory interactions. Provide updates at the GRT meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Review nonclinical, clinical, and CMC documentation and contribute to content. Advise team members of major regulatory issues and provide possible solutions. Lead and coordinate local project team members in developing strategy for applicable documents/activities. Ensure quality and content of submissions to Health Authorities. Assist with development of the global regulatory functional plan. Education and Experience Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs. 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
Associate Director, Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). Job Duties and Responsibilities Manage regional regulatory activities as part of a Global Regulatory Team (GRT). Ensure execution of regional regulatory plans in line with the global registration strategy. Lead preparation, coordination, authoring, and monitoring of submissions (e.g., IND/NDA submissions). Represent GRA on less complex project-related meetings and provide regulatory input. Assess and communicate regulatory requirements ensuring compliance with applicable regulations. Lead the documentation of regulatory interactions. Provide updates at the GRT meetings and project teams as needed. Collaborate effectively with Regulatory Operations Leader (ROL). Review nonclinical, clinical, and CMC documentation and contribute to content. Advise team members of major regulatory issues and provide possible solutions. Lead and coordinate local project team members in developing strategy for applicable documents/activities. Ensure quality and content of submissions to Health Authorities. Assist with development of the global regulatory functional plan. Education and Experience Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer.
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