Description

You will lead and execute regional regulatory strategy for a portfolio of oncology therapies across Europe, engaging with health authorities like EMA and Swissmedic to drive successful approvals and lifecycle management.

Requirements

• Degree in biological sciences, pharmacy, medicine, or related field (advanced degree preferred)
• 12+ years regulatory affairs experience in pharma or biotech
• Significant experience in oncology drug development and checkpoint inhibitors
• Deep understanding of European regulatory frameworks and oncology guidelines
• Proven success in EMA/MHRA submissions and approvals (MAA, Orphan Designations)

Responsibilities

• Lead development and execution of regional regulatory strategy across all stages of development
• Serve as primary contact for regulatory interactions with European agencies (EMA, national authorities)
• Lead preparations for Scientific Advice, Orphan Designation, Pediatric Plans, and Oral Explanations
• Provide regulatory input to clinical trial design, labeling, and post-marketing activities
• Manage and develop a regional regulatory team, prioritizing resources and ensuring compliance