Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Baton Rouge, Louisiana, us, 70873
Sumitomo Pharma Associate Director, Regulatory Affairs Baton Rouge, Louisiana 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). He/she is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio. 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. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports). Represent GRA on 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. Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions. Participate in the promotional materials review committee (PMRC). Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology and FDA regulations. 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. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status.
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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). He/she is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio. 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. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports). Represent GRA on 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. Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions. Participate in the promotional materials review committee (PMRC). Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology and FDA regulations. 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. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status.
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