Regulatory Affairs Consultant (Global Submission Coordinator - EU and US)
ParexelJob Description
When our values align, there's no limit to what we can achieve.
We are seeking a highly organized and detail-orientedRegulatory Affairs Consultant to serve as a Global Submission Coordinator for EU and US markets. This is a key operational role responsible for coordinating all activities required to deliver regulatory submissions across assigned regions, ensuring timely and compliant filings that support our clients' drug development programs.
In this role, you will be at the heart of regulatory submission activities, working collaboratively with global teams, local regulatory representatives, and subject matter experts to ensure successful regulatory outcomes.
Key Responsibilities:
Global Coordination & Stakeholder Management
Coordinate the preparation, compilation, and submissionof new drug applications and lifecycle management (LCM) activities in alignment with submission strategy as defined by the Regional ...
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