Global Regulatory Leader for CNS & Post-Approval (Remote)

Sumitomo Pharma; Richmond (VA); À distance; USD 196 000 - 245 000; Plein temps

Résumé du poste

Sumitomo Pharma is seeking an experienced Regulatory Leader to drive global/regional regulatory strategies for CNS projects in the US. The role reports to the Executive Director of Regulatory Affairs and works within the Biopharma R&D Regulatory Affairs group in the U.S.

Responsibilities include leading submissions, coordinating cross-functional teams, mentoring junior staff, and ensuring compliance with FDA/ICH guidelines. This is primarily remote with periodic on-site meetings.

Qualifications

• Bachelor’s degree in a related field required.
• Master’s degree preferred in scientific discipline.
• Minimum 10 years of relevant biotech/pharma regulatory experience.

Responsabilités

• Leads Global Regulatory Team (GRT) and regulatory activities per global strategy.
• Manages regional US/European regulatory activities within GRT.

Connaissances

Regulatory strategy

Global/regional leadership

FDA/ICH knowledge

Regulatory submissions

Cross-functional collaboration

Communication

Mentoring/leadership

Decision making

Project management

Formation

Bachelor's degree

Master’s degree (preferred)

Outils

Regulatory templates

Description du poste

Sumitomo Pharma is seeking an experienced Regulatory Leader to drive global/regional regulatory strategies for CNS projects in the US. The role reports to the Executive Director of Regulatory Affairs and works within the Biopharma R&D Regulatory Affairs group in the U.S.

Responsibilities include leading submissions, coordinating cross-functional teams, mentoring junior staff, and ensuring compliance with FDA/ICH guidelines. This is primarily remote with periodic on-site meetings.