Project Manager - Regulatory Affairs
The Regulatory Project Coordinator is a key member of the Global Regulatory Affairs' Submission Excellence team, responsible for leading/contributing to the end-to-end planning, coordination, and execution of assigned tasks. The primary objective is to ensure the delivery of business objectives through effective collaboration with cross-functional teams working flexibly across regions.
Achieving this requires strong technical expertise and guidance on procedural and documentation requirements, as well as the ability to work autonomously and as part of a team. Key skills include:
- Regulatory knowledge and experience within the biopharmaceutical industry, clinical site setting, or at a health authority.
- Ability to understand and implement regulatory plans and timelines in support of Health Authority regulatory filings and interaction plans.
- Effective stakeholder management and project management skills, with the ability to communicate and collaborate on multiple levels.
Responsibilities:
The Regulatory Project Coordinator's key responsibilities include creating integrated regulatory plans and timelines, managing Veeva operations, and coordinating reviews/approval processes. They will also organize quality reviews, edits, and copyright compliance, providing purposeful communication to the Global Regulatory Leader and Regulatory Strategist. Furthermore, they will support operational and planning activities related to Health Authority and Competent Authority submissions, including preparation and monitoring of execution of integrated project and submission content plans.
- Részletes információk az állásajánlatról
Vállalat: beBee Careers Hely: Budapest
Budapest, Budapest, HUHozzáadva: 6. 6. 2025
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