Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational 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:
This position reports to Executive Director, Regulatory Affairs and is part of the Biopharma R&D Regulatory Affairs organization based in the US. The role is responsible for serving as the Global Regulatory Leader (GRL) and/or Regional Regulatory Leader (RRL) for assigned projects and works closely with cross‑functional teams to ensure effective collaboration and alignment.
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 CNS 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.
Essential Functions Required for Job:
Leads the Global Regulatory Team (GRT) and regulatory activities for assigned project(s) in line with the global registration strategy of the product
As a Regional Regulatory Lead, if applicable, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
Competently represents RA on project team meetings
Leads and coordinates project team members in developing regulatory strategy for applicable documents/ activities.
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations on electronic submissions
Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions including decisions and outcomes
Provides updates at the Global Regulatory Team meetings and project teams as needed
Collaborates effectively with regulatory operations leader (ROL)
Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
Reviews nonclinical, clinical and CMC documentation (e.g. summary documents, nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
Leads and coordinates local project team members in developing strategy for applicable documents/activities
Ensures the quality and content of all submissions to Health Authorities
Leads the regional health authority meetings, 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, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
Accountable in conjunction with the GRL, if applicable, for developing and maintaining the development core data sheet (DCDS) and company core data sheet (CCDS) if required
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes 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
Leads Global Regulatory Team (GRT), oversees planning and…