Oncology Regulatory Science Lead

revolutionmedicines; USA; Vor Ort; USD 177.000 - 221.000; Vollzeit

Zusammenfassung

Revolution Medicines in the United States is seeking an Associate Director of Regulatory Science to lead regulatory strategy for oncology programs. You will provide regulatory guidance on clinical development, coordinate cross-functional teams, and drive decision-making to ensure timely approvals.

This onsite role at our Redwood City, CA headquarters requires a deep understanding of US FDA and EU EMA processes, with 9+ years in pharma/biotech and 5+ years in Regulatory Affairs.

Qualifikationen

• 9+ years in pharma/biotech with 5+ years in Regulatory Affairs.
• Experience preparing large, complex regulatory submissions.
• Strong cross-functional representation and senior management presentation.
• Deep knowledge of US FDA and EU EMA regulations; EU CTR experience preferred.

Aufgaben

• Plan, prepare, and coordinate regulatory submissions with timelines.
• Assess regulatory risks and communicate mitigation strategies.
• Serve as Regulatory Science SME on cross-functional teams.
• Ensure no significant business interruptions due to regulatory issues.

Kenntnisse

Regulatory Affairs

Cross-functional leadership

Regulatory submissions

Ausbildung

Bachelor's degree in a relevant field

Jobbeschreibung

Revolution Medicines in the United States is seeking an Associate Director of Regulatory Science to lead regulatory strategy for oncology programs. You will provide regulatory guidance on clinical development, coordinate cross-functional teams, and drive decision-making to ensure timely approvals.

This onsite role at our Redwood City, CA headquarters requires a deep understanding of US FDA and EU EMA processes, with 9+ years in pharma/biotech and 5+ years in Regulatory Affairs.