Description

You will lead regulatory strategy and execution for late-stage oncology programs at a company focused on RAS-addicted cancers. You'll oversee global regulatory submissions, manage health authority interactions, and mentor a team of regulatory professionals.

Requirements

• Degree in life sciences, pharmacy, medicine, or related field
• Minimum 12 years in pharma/biotech industry
• Minimum 8 years in Regulatory Affairs with regulatory strategy and leadership
• Prior marketing application filing experience
• Demonstrated success in obtaining health authority approvals

Responsibilities

• Direct global regulatory strategy from registrational studies to marketing applications
• Lead and mentor GRLs/Study Leads in developing global regulatory strategies
• Partner with regional regulatory leads to integrate insights into product strategies
• Communicate aligned global regulatory strategy to management
• Manage review and approval of key regulatory submission documents