Sumitomo Pharma
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 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 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 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 and support successful submission and target labeling
Accountable with the GRL 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) 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
Ethics, professional integrity, and personal values consistent with 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, FDA and ICH regulations/guidances for clinical research and product development
Experience reviewing nonclinical, clinical and CMC documentation and contributing to content as needed
Ability to analyze data from multiple sources to draw conclusions and propose actions
Proven success in NDA/MAA/CTD submissions and approvals
Negotiation skills with composure
Development and writing of regulatory strategy documents
Ability to learn new therapeutic areas as needed
Experience with post-marketing/brand optimization strategies and commercial awareness
Experience interacting with FDA and ex-US Health Authorities
Experience leading teams and Health Authority negotiations and 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
Bachelor’s degree in a related field required.
8 – 12 years with Master’s in a relevant biotech/pharma field; minimum 8 years 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 including merit-based increases, incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves in line with your state. Our time-off policy includes flexible paid time off, 11 paid holidays, an end-of-year shutdown, and 80 hours of paid sick time annually. Total compensation will depend on candidate experience, skills, education and other factors permitted by law.
Disclaimer: The statements describe the general nature and level of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities as needed.
Confidential Data : All information (written, verbal, electronic) that an employee encounters is considered confidential.
Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring plans and activities for SMPA and affiliates 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 and independence. Excellent written and oral communication skills. Proficient with a computer.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity or expression, sexual orientation, disability, veteran status, or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd. is a global company with operations in the U.S., Canada and Europe, focused on oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website 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 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 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 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 and support successful submission and target labeling
Accountable with the GRL 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) 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
Ethics, professional integrity, and personal values consistent with 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, FDA and ICH regulations/guidances for clinical research and product development
Experience reviewing nonclinical, clinical and CMC documentation and contributing to content as needed
Ability to analyze data from multiple sources to draw conclusions and propose actions
Proven success in NDA/MAA/CTD submissions and approvals
Negotiation skills with composure
Development and writing of regulatory strategy documents
Ability to learn new therapeutic areas as needed
Experience with post-marketing/brand optimization strategies and commercial awareness
Experience interacting with FDA and ex-US Health Authorities
Experience leading teams and Health Authority negotiations and 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
Bachelor’s degree in a related field required.
8 – 12 years with Master’s in a relevant biotech/pharma field; minimum 8 years 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 including merit-based increases, incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and leaves in line with your state. Our time-off policy includes flexible paid time off, 11 paid holidays, an end-of-year shutdown, and 80 hours of paid sick time annually. Total compensation will depend on candidate experience, skills, education and other factors permitted by law.
Disclaimer: The statements describe the general nature and level of work and are not exhaustive. All personnel may be required to perform duties outside of their normal responsibilities as needed.
Confidential Data : All information (written, verbal, electronic) that an employee encounters is considered confidential.
Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring plans and activities for SMPA and affiliates 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 and independence. Excellent written and oral communication skills. Proficient with a computer.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity or expression, sexual orientation, disability, veteran status, or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd. is a global company with operations in the U.S., Canada and Europe, focused on oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website or follow us on LinkedIn.
#J-18808-Ljbffr