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 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, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. Job Overview
We are currently 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. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. Responsibilities Manage and Develop Talent May train/mentor junior staff Phases I-IV Research & Development Activities As a Regional Regulatory Lead, manage regional regulatory activities as part of a Global Regulatory Team (GRT) As a part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product Represent GRA on project team meetings Lead and coordinate project team members in developing strategy for applicable documents/activities Plan, coordinate, author, and prepare regulatory submissions; work closely with Regulatory Operations in the electronic submission Assess and communicate regulatory requirements ensuring activities comply with applicable regulations and guidelines Lead documentation of regulatory authority interactions including decisions and outcomes Provide updates at Global Regulatory Team 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 (e.g., nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed Advise team members on major regulatory issues and lead mitigation strategies Coordinate local project team members in developing strategy for applicable documents/activities Ensure the quality and content of all submissions to Health Authorities Lead regional health authority meetings and liaise with local Health Authorities Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan and support successful submissions and target product labeling Develop and maintain the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies; coordinate regulatory compliance activities at a global level Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to the GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT) activities and submissions May create and review SOPs and regulatory department operating procedures
Key Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills Unquestionable ethics and professional integrity aligned with SMPA values Ability to work in a diverse environment and adapt to changing priorities Ability to facilitate team decisions and operate in a matrix organization Sense of urgency and perseverance to achieve results Experience contributing to electronic regulatory submissions and using regulatory templates Advanced understanding of medical terminology and FDA/ICH regulations/guidances for clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contributing to content Ability to analyze data from multiple sources to determine a course of action Proven involvement in NDA/MAA/CTD submissions and approvals Strong negotiation skills with composure Ability to develop and write regulatory strategy documents Willingness to learn new therapeutic areas Experience with post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and ex-US Health Authorities Experience leading teams and Health Authority negotiations/meetings Ability to make complex decisions and defend difficult positions Comfortable presenting to Senior Management High organizational awareness and ability to see interdependencies
Education and Experience
Bachelors degree in a related field required 812 years with Masters of relevant experience in biotech or pharmaceutical industry, with minimum of 8 years focused in regulatory affairs Masters degree required (preferably in a scientific discipline)
Compensation and Benefits
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Compliance and Equal Opportunity
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status; or any other characteristic protected by law. #J-18808-Ljbffr
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, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. Job Overview
We are currently 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. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff. This position works with a high level of autonomy and requires limited coaching and mentoring. Responsibilities Manage and Develop Talent May train/mentor junior staff Phases I-IV Research & Development Activities As a Regional Regulatory Lead, manage regional regulatory activities as part of a Global Regulatory Team (GRT) As a part of the Global Regulatory Team (GRT), lead regulatory activities for assigned project(s) in line with the global registration strategy of the product Represent GRA on project team meetings Lead and coordinate project team members in developing strategy for applicable documents/activities Plan, coordinate, author, and prepare regulatory submissions; work closely with Regulatory Operations in the electronic submission Assess and communicate regulatory requirements ensuring activities comply with applicable regulations and guidelines Lead documentation of regulatory authority interactions including decisions and outcomes Provide updates at Global Regulatory Team 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 (e.g., nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed Advise team members on major regulatory issues and lead mitigation strategies Coordinate local project team members in developing strategy for applicable documents/activities Ensure the quality and content of all submissions to Health Authorities Lead regional health authority meetings and liaise with local Health Authorities Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan and support successful submissions and target product labeling Develop and maintain the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies; coordinate regulatory compliance activities at a global level Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to the GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT) activities and submissions May create and review SOPs and regulatory department operating procedures
Key Core Competencies
Strong verbal and written communication, interpersonal, listening, and organizational skills Unquestionable ethics and professional integrity aligned with SMPA values Ability to work in a diverse environment and adapt to changing priorities Ability to facilitate team decisions and operate in a matrix organization Sense of urgency and perseverance to achieve results Experience contributing to electronic regulatory submissions and using regulatory templates Advanced understanding of medical terminology and FDA/ICH regulations/guidances for clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contributing to content Ability to analyze data from multiple sources to determine a course of action Proven involvement in NDA/MAA/CTD submissions and approvals Strong negotiation skills with composure Ability to develop and write regulatory strategy documents Willingness to learn new therapeutic areas Experience with post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and ex-US Health Authorities Experience leading teams and Health Authority negotiations/meetings Ability to make complex decisions and defend difficult positions Comfortable presenting to Senior Management High organizational awareness and ability to see interdependencies
Education and Experience
Bachelors degree in a related field required 812 years with Masters of relevant experience in biotech or pharmaceutical industry, with minimum of 8 years focused in regulatory affairs Masters degree required (preferably in a scientific discipline)
Compensation and Benefits
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. Compliance and Equal Opportunity
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status; or any other characteristic protected by law. #J-18808-Ljbffr