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. Job Duties and Responsibilities
Manage and Develop Talent – May train/mentor junior staff Phases I-IV Research & Development Activities – As a Regional Regulatory Lead, manage regional (United States and/or European) 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 Competently represents 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 and work closely with Regulatory Operations in electronic submission Assess and communicate regulatory requirements ensuring activities are in compliance 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 and contribute to content as needed Advise team members of major regulatory issues and provide possible solutions and mitigation strategy Lead and coordinate local project team members in developing strategy for applicable documents/activities Ensure the quality and content of all submissions to Health Authorities Lead the regional health authority meetings and liaison with local Health Authority Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan through research and interpretation of related product approvals and regulatory guidance Accountable for developing and maintaining the 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 the GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT), overseeing 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 consistent with the SMPA values Ability to work in a diverse environment Ability to adapt to changing priorities and work effectively 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 and ICH regulations/guidances specific to clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed Understanding of issues, problems and opportunities by comparing data from different sources Proven success/major involvement in NDA/MAA/CTD submissions and approvals Negotiation skills with composure Development and preparation of successful regulatory strategies and ability to contribute to strategy documents Ability to learn new therapeutic areas when necessary Post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and ex-US Health Authorities Experience leading teams and providing leadership in Health Authority negotiations and meetings Ability to make complex decisions and defend difficult positions Comfortable presenting to all levels of the organization, including Senior Management High degree of organizational awareness and ability to connect interdependencies Education and Experience
Bachelor’s degree in a related field required 8 – 12 years with Master’s in a relevant field in biotech or pharmaceutical industry with minimum 8 years in regulatory affairs Master’s 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 merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves 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. Disclaimer: The above statements describe the general nature and level of work. Confidential Data
: All information encountered is considered confidential. Compliance
: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures to ensure plans and activities are carried out with best industry practices and high ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. An employer who violates this law shall be subject to penalties. Mental/Physical Requirements
: Fast paced environment with multiple demands. Requires initiative, independence, and excellent written and oral communication skills. Requires ability to use a computer for extended periods. 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, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company 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. With a diverse pipeline of 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. Our Mission and Vision: To contribute to society through innovative research and development for the betterment of healthcare and longer, healthier lives worldwide.
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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, 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. Job Duties and Responsibilities
Manage and Develop Talent – May train/mentor junior staff Phases I-IV Research & Development Activities – As a Regional Regulatory Lead, manage regional (United States and/or European) 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 Competently represents 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 and work closely with Regulatory Operations in electronic submission Assess and communicate regulatory requirements ensuring activities are in compliance 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 and contribute to content as needed Advise team members of major regulatory issues and provide possible solutions and mitigation strategy Lead and coordinate local project team members in developing strategy for applicable documents/activities Ensure the quality and content of all submissions to Health Authorities Lead the regional health authority meetings and liaison with local Health Authority Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan through research and interpretation of related product approvals and regulatory guidance Accountable for developing and maintaining the 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 the GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT), overseeing 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 consistent with the SMPA values Ability to work in a diverse environment Ability to adapt to changing priorities and work effectively 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 and ICH regulations/guidances specific to clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed Understanding of issues, problems and opportunities by comparing data from different sources Proven success/major involvement in NDA/MAA/CTD submissions and approvals Negotiation skills with composure Development and preparation of successful regulatory strategies and ability to contribute to strategy documents Ability to learn new therapeutic areas when necessary Post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and ex-US Health Authorities Experience leading teams and providing leadership in Health Authority negotiations and meetings Ability to make complex decisions and defend difficult positions Comfortable presenting to all levels of the organization, including Senior Management High degree of organizational awareness and ability to connect interdependencies Education and Experience
Bachelor’s degree in a related field required 8 – 12 years with Master’s in a relevant field in biotech or pharmaceutical industry with minimum 8 years in regulatory affairs Master’s 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 merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves 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. Disclaimer: The above statements describe the general nature and level of work. Confidential Data
: All information encountered is considered confidential. Compliance
: Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures to ensure plans and activities are carried out with best industry practices and high ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. An employer who violates this law shall be subject to penalties. Mental/Physical Requirements
: Fast paced environment with multiple demands. Requires initiative, independence, and excellent written and oral communication skills. Requires ability to use a computer for extended periods. 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, marital or domestic partnership status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. Sumitomo Pharma Co., Ltd. is a global pharmaceutical company 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. With a diverse pipeline of 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. Our Mission and Vision: To contribute to society through innovative research and development for the betterment of healthcare and longer, healthier lives worldwide.
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