Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Boise, Idaho, United States, 83708
Sumitomo Pharma Associate Director, Regulatory Affairs Boise, Idaho 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. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. 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. Depending on the candidate’s skill-set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage projects and/or commercial asset such as Gemtessa or Aptiom (i.e., at least 5 years post-launch). 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 global regulatory leader (GRL). Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests. Represent GRA on less complex project related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring activities are in 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). Maintain professional working relationship with colleagues, fostering collaboration, and idea sharing. Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions, and lead the mitigation strategy. 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 through research, review and interpretation of related product approvals and current regulatory guidance documents. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion. 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. 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. 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. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. 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. Depending on the candidate’s skill-set, may also be assigned as a Global Regulatory Leader (GRL) with full regulatory responsibility for one or more earlier stage projects and/or commercial asset such as Gemtessa or Aptiom (i.e., at least 5 years post-launch). 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 global regulatory leader (GRL). Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests. Represent GRA on less complex project related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring activities are in 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). Maintain professional working relationship with colleagues, fostering collaboration, and idea sharing. Review nonclinical, clinical and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and provide possible solutions, and lead the mitigation strategy. 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 through research, review and interpretation of related product approvals and current regulatory guidance documents. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion. 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. 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. 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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