Global Regulatory Affairs Project Lead

Job Overview

This role involves overseeing global regulatory projects and contributing to product success through innovative strategies.

• Strategic management of regulatory submissions and international initiatives
• Cross-functional coordination with various teams including Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Manufacturing & Supply, Legal, Business Development, and Commercial
• Development of global regulatory plans and identification of risks and opportunities

The ideal candidate will have a degree in Health Sciences, fluency in English, and at least 3 years of experience in Regulatory Affairs and Project Management within the biopharmaceutical sector.

Key Responsibilities :

Project Management

Managing regulatory submissions and global strategies

Collaboration and Coordination

Cross-functional coordination with Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Manufacturing & Supply, Legal, Business Development, and Commercial teams

Regulatory Planning

Defining global regulatory strategies and identifying risks and opportunities

Requirements :

Health Sciences degree, English fluency, and at least 3 years of experience in Regulatory Affairs and Project Management within the biopharmaceutical sector