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 https://www.us.sumitomo-pharma.com 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 Represent GRA on project team meetings Leads and coordinates project team members in developing strategy for applicable documents/activities Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines Leads documentation of regulatory authority interactions including decisions and outcomes Provides updates at the Global Regulatory Team meetings and project teams as needed Collaborates effectively with regulatory operations leader (ROL) Maintains professional working relationship with colleagues, fostering collaboration and idea sharing Reviews nonclinical, clinical and CMC documentation and contributes to content as needed Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy Leads and coordinates local project team members in developing strategy for applicable documents/activities Ensures the quality and content of all submissions to Health Authorities Leads 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, review and interpretation of related product approvals and regulatory guidance to support successful submissions and target product labeling Accountable for developing and maintaining the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and adhere to regulatory internal policies and processes Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to the GRT, project teams, and governance boards as needed Leads Global Regulatory Team (GRT), oversees 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 required Unquestionable ethics, professional integrity, and personal values consistent with SMPA values Ability to work in a diverse environment Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization Demonstrated 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 general product development in the pharmaceutical industry Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed Understands issues, problems and opportunities by comparing data from different sources to draw conclusions Proven success/major involvement in NDA/MAA/CTD submissions and approval Capable of effectively negotiating with others while maintaining composure Development and preparation of successful regulatory strategies and the ability to contribute to regulatory strategy documents Ability to learn new therapeutic areas when necessary Prior history with post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and ex-US Health Authorities Experience in 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 understand interdependencies Education and Experience
Bachelor’s degree in a related field required 8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs Master’s degree required (preferably in a scientific discipline) 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, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our time-off policy includes flexible paid time off, holidays, paid sick time, and other leaves. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. 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. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures. 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 high initiative and independence. 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 without regard to protected characteristics as defined 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. (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 https://www.us.sumitomo-pharma.com 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 Represent GRA on project team meetings Leads and coordinates project team members in developing strategy for applicable documents/activities Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines Leads documentation of regulatory authority interactions including decisions and outcomes Provides updates at the Global Regulatory Team meetings and project teams as needed Collaborates effectively with regulatory operations leader (ROL) Maintains professional working relationship with colleagues, fostering collaboration and idea sharing Reviews nonclinical, clinical and CMC documentation and contributes to content as needed Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy Leads and coordinates local project team members in developing strategy for applicable documents/activities Ensures the quality and content of all submissions to Health Authorities Leads 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, review and interpretation of related product approvals and regulatory guidance to support successful submissions and target product labeling Accountable for developing and maintaining the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and adhere to regulatory internal policies and processes Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to the GRT, project teams, and governance boards as needed Leads Global Regulatory Team (GRT), oversees 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 required Unquestionable ethics, professional integrity, and personal values consistent with SMPA values Ability to work in a diverse environment Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization Demonstrated 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 general product development in the pharmaceutical industry Experience reviewing nonclinical, clinical and CMC documentation and contribute to content as needed Understands issues, problems and opportunities by comparing data from different sources to draw conclusions Proven success/major involvement in NDA/MAA/CTD submissions and approval Capable of effectively negotiating with others while maintaining composure Development and preparation of successful regulatory strategies and the ability to contribute to regulatory strategy documents Ability to learn new therapeutic areas when necessary Prior history with post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and ex-US Health Authorities Experience in 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 understand interdependencies Education and Experience
Bachelor’s degree in a related field required 8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs Master’s degree required (preferably in a scientific discipline) 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, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our time-off policy includes flexible paid time off, holidays, paid sick time, and other leaves. Total compensation will depend on candidate experience, skills, education and other factors permitted by law. 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. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures. 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 high initiative and independence. 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 without regard to protected characteristics as defined by law.
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