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. Responsibilities
Manage and Develop Talent — may train/mentor junior staff Phase 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; work closely with Regulatory Operations in the electronic submission Assess and communicate regulatory requirements ensuring 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 lead 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 Authorities Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan and support successful submission and labeling Maintain development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies; coordinate global regulatory compliance activities Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions May create and review SOPs and regulatory department operating procedures Key Core Competencies
Strong verbal and written communication skills; interpersonal and organizational skills Ethical integrity aligned with SMPA values Ability to work in a diverse environment and adapt to changing priorities 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/guidances related to clinical research and product development Experience reviewing nonclinical, clinical, and CMC documentation and contributing to content Proven success/major involvement in NDA/MAA/CTD submissions and approvals Negotiation skills with maintainable composure Development and writing of regulatory strategies Ability to learn new therapeutic areas; post-marketing/brand optimization experience 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 challenging positions Comfort presenting to Senior Management; high organizational awareness Education and Experience
Bachelor’s degree in a related field required 8–12 years with Master’s in a relevant biotech/pharmaceutical field; minimum of 8 years focused in regulatory affairs Master’s degree required (preferably in a scientific discipline) Compensation and Benefits
The base salary range for this role is $187,520 to $234,400. Base salary is part of a total rewards package including merit-based salary increases, short incentive plan participation, eligibility for 401(k), medical/dental/vision/life/disability insurances, and leaves. Time-off includes flexible PTO, 11 paid holidays, and additional time off during a year-end shutdown. Total compensation will depend on candidate experience and qualifications. Disclaimer: This description is not exhaustive of all responsibilities. Duties may be added or changed as needed. Compliance and Equal 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.
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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. Responsibilities
Manage and Develop Talent — may train/mentor junior staff Phase 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; work closely with Regulatory Operations in the electronic submission Assess and communicate regulatory requirements ensuring 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 lead 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 Authorities Document owner of briefing book documentation to Health Authorities Assist with development of the global regulatory functional plan and support successful submission and labeling Maintain development core data sheet (DCDS) if required Ensure compliance with global regulatory requirements and internal policies; coordinate global regulatory compliance activities Provide strategic review of dossier summaries, expert statements, and development management plans Provide updates to GRT, project teams, and governance boards as needed Lead Global Regulatory Team (GRT) planning and execution of global regulatory activities and submissions May create and review SOPs and regulatory department operating procedures Key Core Competencies
Strong verbal and written communication skills; interpersonal and organizational skills Ethical integrity aligned with SMPA values Ability to work in a diverse environment and adapt to changing priorities 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/guidances related to clinical research and product development Experience reviewing nonclinical, clinical, and CMC documentation and contributing to content Proven success/major involvement in NDA/MAA/CTD submissions and approvals Negotiation skills with maintainable composure Development and writing of regulatory strategies Ability to learn new therapeutic areas; post-marketing/brand optimization experience 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 challenging positions Comfort presenting to Senior Management; high organizational awareness Education and Experience
Bachelor’s degree in a related field required 8–12 years with Master’s in a relevant biotech/pharmaceutical field; minimum of 8 years focused in regulatory affairs Master’s degree required (preferably in a scientific discipline) Compensation and Benefits
The base salary range for this role is $187,520 to $234,400. Base salary is part of a total rewards package including merit-based salary increases, short incentive plan participation, eligibility for 401(k), medical/dental/vision/life/disability insurances, and leaves. Time-off includes flexible PTO, 11 paid holidays, and additional time off during a year-end shutdown. Total compensation will depend on candidate experience and qualifications. Disclaimer: This description is not exhaustive of all responsibilities. Duties may be added or changed as needed. Compliance and Equal 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.
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