About this role

Coordinate the preparation, compilation, and submission of new drug applications and lifecycle management (LCM) activities
Coordinate closely with Global Submission Coordinators to ensure completeness of core documentation
Organize submission team meetings and facilitate effective communication among all stakeholders
Prepare Submission Content Plans (SCP) based on country-specific regulatory requirements
Coordinate, request, and track documentation from relevant SMEs to ensure timely and complete submission readiness
Provide regular updates to the submission team on status and timelines
Draft M1 documents as required and coordinate their review with LRR or RPR
Support labeling preparation, notably in Artwork management system and change control system
Ensure dispatch of non-eCTD regulatory packages to LRR and RPR
Track dispatched documentation for each country
Update Veeva as required, including uploading each question received by Health Authorities in a record HAI

University degree in Life Sciences discipline
3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
Regulatory submission strategy and execution experience, ideally global
Strong understanding of regional regulatory submission processes
Experience with different international regulatory submission routes preferred (e.g., ACCESS, reliance pathways)
Excellent project management and organizational skills
Proficiency in regulatory tracking systems and Microsoft Office Suite
Fluent in English, written and spoken.

Senior Regulatory Affairs Associate – Regional Submission Coordinator

Key skills