Sumitomo Pharma
Overview
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 oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company has marketed products in the U.S., Canada, and Europe and a diverse pipeline of early- to late-stage assets. For more information, visit the SMPA website or follow on LinkedIn. Job Overview
We are seeking a dynamic, highly motivated, and experienced individual for the position of
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US and will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. The role leads the development and implementation of regulatory strategy from proof of concept through development, registration, and post-approval for projects within the company portfolio. This position may train/mentor junior staff and works with a high level of autonomy with limited coaching and mentoring. Responsibilities
Lead the development and implementation of regulatory strategy from proof of concept to post-approval for assigned projects within the portfolio. As the Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). As part of the Global Regulatory Team, lead regulatory activities for assigned project(s) in line with the global registration strategy of the product. Represent GRA in project team meetings; lead and coordinate team members in developing strategy for applicable documents and activities. Plan, coordinate, author, and prepare regulatory submissions; work with Regulatory Operations on electronic submissions. Assess and communicate regulatory requirements ensuring activities comply with applicable regulations and guidelines. Document regulatory authority interactions, including decisions and outcomes. Provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate with regulatory operations leader (ROL) and maintain professional working relationships with colleagues to foster collaboration and idea sharing. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and lead mitigation strategies. Ensure the quality and content of all submissions to Health Authorities; lead regional health authority meetings and liaison with local Health Authorities. Document owner of briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan and maintain development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and coordinate regulatory compliance activities at a global level. Provide strategic review of dossier summaries, expert statements, and development management plans; provide updates to GRT, project teams, and governance boards as needed. Lead the Global Regulatory Team (GRT) and oversee planning and execution of global regulatory activities and submissions. May be responsible for creating and reviewing SOPs and regulatory department operating procedures. Key Core Competencies
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills. Unquestionable ethics, professional integrity, and personal values aligned with SMPA values. Ability to work in a diverse environment and adapt to changing priorities in a matrix organization. Ability to facilitate appropriate team decisions; sense of urgency and perseverance to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology and FDA/ICH regulations and guidances relevant to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation and contributing content as needed. Ability to analyze data from multiple sources, draw conclusions, and determine action or solutions. Proven involvement in NDA/MAA/CTD submissions and approvals; strong negotiation and leadership in Health Authority negotiations and meetings. Ability to learn new therapeutic areas and develop regulatory strategies; familiarity with post-marketing/brand optimization strategies and commercial awareness. Experience interacting with the FDA and ex-US Health Authorities. Ability to present to all levels of the organization, including Senior Management; high organizational awareness and an ability to see interdependencies. Education and Experience
Bachelor’s degree in a related field required. 8–12 years of relevant experience in biotech or pharmaceutical industry with a minimum of 8 years focused in regulatory affairs; Master’s degree preferred. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits
The base salary range is $187,520 to $234,400. Base salary includes potential merit-based increases and eligibility for our 401(k) plan, medical/dental/vision, life and disability insurances, and leaves as per state law. Time-off includes flexible paid time off, 11 paid holidays, December shutdown, and paid sick time. Total compensation depends on candidate experience, skills, education, and other factors permitted by law. Privacy, Compliance, and Equal Opportunity
Disclaimer: The statements describe the general nature and level of work; responsibilities may be adjusted. All personnel may be required to perform duties outside of their normal responsibilities as needed. Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory, legal, and operational rules and procedures. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with operations in the U.S., Canada, and Europe, focused on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and CNS. For more information, visit the SMPA website or LinkedIn. The company strives to make its application process accessible. For accessibility assistance, contact reasonableaccomodations@us.sumitomo-pharma.com (for accommodation requests only). Our Mission: To broadly contribute to society through innovative R&D for better healthcare worldwide. Our Vision: For Longer and Healthier Lives, we unlock the future with cutting-edge technology and ideas.
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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 oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. The company has marketed products in the U.S., Canada, and Europe and a diverse pipeline of early- to late-stage assets. For more information, visit the SMPA website or follow on LinkedIn. Job Overview
We are seeking a dynamic, highly motivated, and experienced individual for the position of
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US and will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. The role leads the development and implementation of regulatory strategy from proof of concept through development, registration, and post-approval for projects within the company portfolio. This position may train/mentor junior staff and works with a high level of autonomy with limited coaching and mentoring. Responsibilities
Lead the development and implementation of regulatory strategy from proof of concept to post-approval for assigned projects within the portfolio. As the Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT). As part of the Global Regulatory Team, lead regulatory activities for assigned project(s) in line with the global registration strategy of the product. Represent GRA in project team meetings; lead and coordinate team members in developing strategy for applicable documents and activities. Plan, coordinate, author, and prepare regulatory submissions; work with Regulatory Operations on electronic submissions. Assess and communicate regulatory requirements ensuring activities comply with applicable regulations and guidelines. Document regulatory authority interactions, including decisions and outcomes. Provide updates at Global Regulatory Team meetings and project teams as needed. Collaborate with regulatory operations leader (ROL) and maintain professional working relationships with colleagues to foster collaboration and idea sharing. Review nonclinical, clinical, and CMC documentation and contribute to content as needed. Advise team members of major regulatory issues and lead mitigation strategies. Ensure the quality and content of all submissions to Health Authorities; lead regional health authority meetings and liaison with local Health Authorities. Document owner of briefing book documentation to Health Authorities. Assist with development of the global regulatory functional plan and maintain development core data sheet (DCDS) if required. Ensure compliance with global regulatory requirements and coordinate regulatory compliance activities at a global level. Provide strategic review of dossier summaries, expert statements, and development management plans; provide updates to GRT, project teams, and governance boards as needed. Lead the Global Regulatory Team (GRT) and oversee planning and execution of global regulatory activities and submissions. May be responsible for creating and reviewing SOPs and regulatory department operating procedures. Key Core Competencies
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills. Unquestionable ethics, professional integrity, and personal values aligned with SMPA values. Ability to work in a diverse environment and adapt to changing priorities in a matrix organization. Ability to facilitate appropriate team decisions; sense of urgency and perseverance to achieve results. Experience contributing to electronic regulatory submissions and working with regulatory templates. Advanced understanding of medical terminology and FDA/ICH regulations and guidances relevant to clinical research and product development. Experience reviewing nonclinical, clinical, and CMC documentation and contributing content as needed. Ability to analyze data from multiple sources, draw conclusions, and determine action or solutions. Proven involvement in NDA/MAA/CTD submissions and approvals; strong negotiation and leadership in Health Authority negotiations and meetings. Ability to learn new therapeutic areas and develop regulatory strategies; familiarity with post-marketing/brand optimization strategies and commercial awareness. Experience interacting with the FDA and ex-US Health Authorities. Ability to present to all levels of the organization, including Senior Management; high organizational awareness and an ability to see interdependencies. Education and Experience
Bachelor’s degree in a related field required. 8–12 years of relevant experience in biotech or pharmaceutical industry with a minimum of 8 years focused in regulatory affairs; Master’s degree preferred. Master’s degree required (preferably in a scientific discipline). Compensation and Benefits
The base salary range is $187,520 to $234,400. Base salary includes potential merit-based increases and eligibility for our 401(k) plan, medical/dental/vision, life and disability insurances, and leaves as per state law. Time-off includes flexible paid time off, 11 paid holidays, December shutdown, and paid sick time. Total compensation depends on candidate experience, skills, education, and other factors permitted by law. Privacy, Compliance, and Equal Opportunity
Disclaimer: The statements describe the general nature and level of work; responsibilities may be adjusted. All personnel may be required to perform duties outside of their normal responsibilities as needed. Confidential Data : All information encountered is confidential. Compliance : Achieve and maintain compliance with regulatory, legal, and operational rules and procedures. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration without regard to protected characteristics. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company with operations in the U.S., Canada, and Europe, focused on oncology, urology, women’s health, rare diseases, psychiatry & neurology, and CNS. For more information, visit the SMPA website or LinkedIn. The company strives to make its application process accessible. For accessibility assistance, contact reasonableaccomodations@us.sumitomo-pharma.com (for accommodation requests only). Our Mission: To broadly contribute to society through innovative R&D for better healthcare worldwide. Our Vision: For Longer and Healthier Lives, we unlock the future with cutting-edge technology and ideas.
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