Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Richmond, Virginia, United States, 23214
Sumitomo Pharma Associate Director, Regulatory Affairs Richmond, Virginia Apply Now
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website
here
or follow us on
LinkedIn . 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. This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. This position has a moderate-high level of autonomy but may require some coaching and mentoring. 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 and responses to HA information requests. Represent GRA on project related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Document 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. 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. Ensure compliance with global regulatory requirements and coordinate regulatory compliance activities. Promotional Activities Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs, and Clinical Research. Conduct regulatory review of promotional and non-promotional materials. Ensure all submissions to the Office of Prescription Drug Promotion (OPDP) are complete. Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills required. Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values. Ability to work in a diverse environment. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology, and FDA and ICH regulations/guidances. Experience reviewing nonclinical, clinical and CMC documentation. Ability to negotiate effectively while maintaining composure. Experience interacting with the FDA. Experience in successfully leading teams. Proven success in major submissions and approval. 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. Compensation 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 merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, and various insurances. Our robust time-off policy includes unlimited paid time off and 80 hours of paid sick time upon hire and each year thereafter. Equal Employment Opportunity Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to any characteristic protected by law.
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Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada, and Europe focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website
here
or follow us on
LinkedIn . 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. This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. This position has a moderate-high level of autonomy but may require some coaching and mentoring. 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 and responses to HA information requests. Represent GRA on project related meetings and provide regulatory input as appropriate. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines. Document 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. 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. Ensure compliance with global regulatory requirements and coordinate regulatory compliance activities. Promotional Activities Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs, and Clinical Research. Conduct regulatory review of promotional and non-promotional materials. Ensure all submissions to the Office of Prescription Drug Promotion (OPDP) are complete. Key Core Competencies Strong verbal and written communication, interpersonal, listening, and organizational skills required. Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values. Ability to work in a diverse environment. Experience contributing to electronic regulatory submissions. Solid understanding of medical terminology, and FDA and ICH regulations/guidances. Experience reviewing nonclinical, clinical and CMC documentation. Ability to negotiate effectively while maintaining composure. Experience interacting with the FDA. Experience in successfully leading teams. Proven success in major submissions and approval. 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. Compensation 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 merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, and various insurances. Our robust time-off policy includes unlimited paid time off and 80 hours of paid sick time upon hire and each year thereafter. Equal Employment Opportunity Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to any characteristic protected by law.
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