Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Montpelier, Vermont, us, 05604
Sumitomo Pharma Associate Director, Regulatory Affairs Montpelier, Vermont 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 (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures). Represent GRA on less complex project-related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Lead the documentation of regulatory interactions including decisions and outcomes. 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 as needed. Advise team members of major regulatory issues and provide possible solutions. Ensure quality and content of submissions to Health Authorities. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research. 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 the biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs. 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. Must be able to exercise appropriate judgment as necessary. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
#J-18808-Ljbffr
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 (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures). Represent GRA on less complex project-related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Lead the documentation of regulatory interactions including decisions and outcomes. 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 as needed. Advise team members of major regulatory issues and provide possible solutions. Ensure quality and content of submissions to Health Authorities. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research. 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 the biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs. 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. Must be able to exercise appropriate judgment as necessary. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
#J-18808-Ljbffr