Sumitomo Pharma
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
May train/mentor junior staff As a Regional Regulatory Lead, manage regional 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 the 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 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 relationships with colleagues to foster 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 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 through review of product approvals and current regulatory guidance Accountable, with the GRL, for developing and maintaining the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies, and coordinate regulatory compliance activities globally 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 aligned 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/ICH regulations/guidances related to 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, identify issues, and develop solutions Proven success in NDA/MAA/CTD submissions and approvals Ability to negotiate effectively while maintaining composure Development and preparation of regulatory strategies and the ability to contribute to strategy documents Ability to learn new therapeutic areas as needed Experience with 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 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 in a relevant field, with a 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, 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 time-off policy includes flexible paid time off, 11 paid holidays, and additional time off during the year-end period; 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 and are not exhaustive of duties. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring plans and activities for Sumitomo Pharma America (SMPA) and affiliates are conducted 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. Mental/Physical Requirements : Fast-paced environment with multiple demands. Requires initiative and independence. Excellent written and oral communication skills. Prolonged computer use may be required. 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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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
May train/mentor junior staff As a Regional Regulatory Lead, manage regional 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 the 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 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 relationships with colleagues to foster 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 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 through review of product approvals and current regulatory guidance Accountable, with the GRL, for developing and maintaining the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies, and coordinate regulatory compliance activities globally 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 aligned 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/ICH regulations/guidances related to 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, identify issues, and develop solutions Proven success in NDA/MAA/CTD submissions and approvals Ability to negotiate effectively while maintaining composure Development and preparation of regulatory strategies and the ability to contribute to strategy documents Ability to learn new therapeutic areas as needed Experience with 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 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 in a relevant field, with a 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, 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 time-off policy includes flexible paid time off, 11 paid holidays, and additional time off during the year-end period; 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 and are not exhaustive of duties. All personnel may be required to perform duties outside of their normal responsibilities from time to time. Confidential Data : All information encountered is considered confidential. Compliance : Achieve and maintain compliance with all applicable regulatory, legal and operational rules and procedures, ensuring plans and activities for Sumitomo Pharma America (SMPA) and affiliates are conducted 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. Mental/Physical Requirements : Fast-paced environment with multiple demands. Requires initiative and independence. Excellent written and oral communication skills. Prolonged computer use may be required. 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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