Global Regulatory Leader, CNS & Oncology (Remote)

Sumitomo Pharma; Olympia (WA); Remote; USD 196.000 - 245.000; Vollzeit

Zusammenfassung

Sumitomo Pharma seeks a Senior Regulatory Leader to drive regulatory strategy from concept through post-approval for CNS projects in the US. You will lead the Global Regulatory Team, coordinate regional activities, and mentor junior staff while ensuring compliance with global regulatory requirements.

Primarily remote role with global responsibilities, travel as needed. Requires a Bachelor’s and a Master’s degree with 10+ years in biotech/pharma regulatory affairs.

Qualifikationen

• Bachelor’s degree in a related field required.
• Master’s degree preferred (scientific discipline).
• Minimum 10 years of relevant experience in biotech or pharmaceutical industry.
• Experience leading regulatory teams and negotiations with Health Authorities.

Aufgaben

• Leads the Global Regulatory Team (GRT) and regulatory activities for assigned projects.
• Manages regional regulatory activities for US and/or Europe as part of a GRT.
• Plans, authors, and prepares regulatory submissions and coordinates with Regulatory Operations.
• Advises on regulatory strategy, ensures compliance with FDA/ICH guidelines.
• Mentors junior staff and coordinates cross-functional teams.

Kenntnisse

Global Regulatory Leadership

Regulatory Strategy

FDA/ICH Regulations

Regulatory Submissions

Cross-functional Collaboration

Project Leadership

Communication Skills

Mentoring

Ausbildung

Bachelor's degree

Master's degree

Jobbeschreibung

Sumitomo Pharma seeks a Senior Regulatory Leader to drive regulatory strategy from concept through post-approval for CNS projects in the US. You will lead the Global Regulatory Team, coordinate regional activities, and mentor junior staff while ensuring compliance with global regulatory requirements.

Primarily remote role with global responsibilities, travel as needed. Requires a Bachelor’s and a Master’s degree with 10+ years in biotech/pharma regulatory affairs.