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.
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 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 and work closely with Regulatory Operations in the 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 strategies.
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 Authorities; document ownership of briefing book documentation to Health Authorities.
Assist with development of the global regulatory functional plan and support successful submissions and target product labeling.
Coordinate for development of the development core data sheet (DCDS) if required, in conjunction with the GRL.
Ensure global regulatory compliance and adherence to internal policies; coordinate regulatory compliance activities at a global level.
Provide strategic review of dossier summaries, expert statements, and development management plans; update GRT and governance boards as needed.
Lead Global Regulatory Team (GRT) activities and submissions planning and execution.
May create and review 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; 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/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 actions.
Proven success in NDA/MAA/CTD submissions and approvals; experience negotiating with Health Authorities.
Ability to develop and write regulatory strategies and to learn new therapeutic areas when necessary.
Commercial awareness and experience with post-marketing/brand optimization strategies; experience with FDA and ex-US Health Authorities.
Experience leading teams and guiding Health Authority negotiations and meetings.
Ability to make complex decisions and defend positions; comfortable presenting to Senior Management.
High organizational awareness and ability to understand interdependencies and the big picture.
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 a minimum of 8 years focused in regulatory affairs.
Master’s degree required (preferably in a scientific discipline).
Salary 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, including base salary to be offered, will depend on elements unique to each candidate, including 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 of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the best industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
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 liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information or any other characteristic protected by law.
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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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.
#J-18808-Ljbffr
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 (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
As 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 and work closely with Regulatory Operations in the 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 strategies.
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 Authorities; document ownership of briefing book documentation to Health Authorities.
Assist with development of the global regulatory functional plan and support successful submissions and target product labeling.
Coordinate for development of the development core data sheet (DCDS) if required, in conjunction with the GRL.
Ensure global regulatory compliance and adherence to internal policies; coordinate regulatory compliance activities at a global level.
Provide strategic review of dossier summaries, expert statements, and development management plans; update GRT and governance boards as needed.
Lead Global Regulatory Team (GRT) activities and submissions planning and execution.
May create and review 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; 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/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 actions.
Proven success in NDA/MAA/CTD submissions and approvals; experience negotiating with Health Authorities.
Ability to develop and write regulatory strategies and to learn new therapeutic areas when necessary.
Commercial awareness and experience with post-marketing/brand optimization strategies; experience with FDA and ex-US Health Authorities.
Experience leading teams and guiding Health Authority negotiations and meetings.
Ability to make complex decisions and defend positions; comfortable presenting to Senior Management.
High organizational awareness and ability to understand interdependencies and the big picture.
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 a minimum of 8 years focused in regulatory affairs.
Master’s degree required (preferably in a scientific discipline).
Salary 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, including base salary to be offered, will depend on elements unique to each candidate, including 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 of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the best industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
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 liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information or any other characteristic protected by law.
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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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.
#J-18808-Ljbffr