Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Montgomery, Alabama, United States, 36136
Sumitomo Pharma Associate Director, Regulatory Affairs Montgomery, Alabama 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. This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. 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, 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 relationships 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. 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. Accountable for developing and maintaining the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills required. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology and FDA and ICH regulations. Experience reviewing nonclinical, clinical and CMC documentation. Ability to negotiate effectively. Experience interacting with the FDA. Proven success in major submissions and approvals. 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 a minimum of 6 years focused in Regulatory Affairs. The base salary range for this role is $153,700 to $192,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, and eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. 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. 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. This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. 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, 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 relationships 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. 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. Accountable for developing and maintaining the development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills required. Unquestionable ethics and professional integrity. Ability to work in a diverse environment. Demonstrated ability to adapt to changing priorities. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology and FDA and ICH regulations. Experience reviewing nonclinical, clinical and CMC documentation. Ability to negotiate effectively. Experience interacting with the FDA. Proven success in major submissions and approvals. 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 a minimum of 6 years focused in Regulatory Affairs. The base salary range for this role is $153,700 to $192,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, and eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. 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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