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) in the United States and/or Europe 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 electronic submissions 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 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 through research, review, and interpretation of related product approvals and regulatory guidance Develop and maintain the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies, coordinating 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), oversee 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 Facilitation of 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 relevant to clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contributing content as needed Ability to analyze data from different sources to draw conclusions and decide actions Proven success in NDA/MAA/CTD submissions and approvals Negotiation skills with maintained composure Development and preparation of regulatory strategies and contribution to regulatory strategy documents Ability to learn new therapeutic areas when necessary Experience with post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and other Health Authorities outside the US Experience leading teams and providing leadership in Health Authority negotiations and meetings Ability to make complex decisions and defend challenging positions Comfortable presenting to all levels of the organization including Senior Management High level 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 eligibility for merit-based salary increases, incentive plans, 401(k), medical/dental/vision/life and disability insurances, and leaves per state. Our time-off policy includes flexible paid time off, 11 paid holidays, and additional time off for a year-end shutdown. Total compensation will depend on candidate experience and other factors permitted by law. Compliance and Equal Employment Opportunity 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. Confidential Data : All information encountered is considered confidential. Note : This job description reflects management’s assignment of essential functions and is not intended to be an exhaustive list of duties. It may be revised at any time.
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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) in the United States and/or Europe 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 electronic submissions 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 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 through research, review, and interpretation of related product approvals and regulatory guidance Develop and maintain the development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies, coordinating 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), oversee 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 Facilitation of 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 relevant to clinical research and product development Experience reviewing nonclinical, clinical and CMC documentation and contributing content as needed Ability to analyze data from different sources to draw conclusions and decide actions Proven success in NDA/MAA/CTD submissions and approvals Negotiation skills with maintained composure Development and preparation of regulatory strategies and contribution to regulatory strategy documents Ability to learn new therapeutic areas when necessary Experience with post-marketing/brand optimization strategies and commercial awareness Experience interacting with the FDA and other Health Authorities outside the US Experience leading teams and providing leadership in Health Authority negotiations and meetings Ability to make complex decisions and defend challenging positions Comfortable presenting to all levels of the organization including Senior Management High level 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 eligibility for merit-based salary increases, incentive plans, 401(k), medical/dental/vision/life and disability insurances, and leaves per state. Our time-off policy includes flexible paid time off, 11 paid holidays, and additional time off for a year-end shutdown. Total compensation will depend on candidate experience and other factors permitted by law. Compliance and Equal Employment Opportunity 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. Confidential Data : All information encountered is considered confidential. Note : This job description reflects management’s assignment of essential functions and is not intended to be an exhaustive list of duties. It may be revised at any time.
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