Regulatory Operations Specialist
About the Job
The Regulatory Project Coordinator will play a crucial role in shaping the future of medicine. This individual will be responsible for leading/contributing to end-to-end planning, coordination, and execution of assigned tasks within the Global Regulatory Affairs' Submission Excellence team.
Key responsibilities include:
- Creating integrated regulatory plans and timelines in support of Health Authority regulatory filings and interaction plans and timelines for all regulatory deliverables.
- Managing Veeva operations, coordinating reviews/approval processes for regulatory-owned deliverables, organizing quality reviews, edits, and copyright compliance.
- Providing purposeful communication to the Global Regulatory Leader and Regulatory Strategist, particularly when issues are encountered.
Main Responsibilities:
The Regulatory Project Coordinator 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. This includes simple submissions (e. g. , meeting requests, briefing packages, designation requests) and increasingly complex submissions (INDs, NDAs, BLAs). Additionally, they will perform project management tasks that support the Global Regulatory Team, such as Common Technical Document development, Global Submission Strategy planning, and Investigational New Drug amendments. They will also coordinate with the Global Regulatory Leader for input, maintenance, and revision of Research and Development Portfolio Management project plans.
- Részletes információk az állásajánlatról
Vállalat: beBee Careers Hely: Budapest
Budapest, Budapest, HUHozzáadva: 4. 6. 2025
Aktív álláslehetőségek
A friss munkaajánlatra Ön elsőként jelentkezhet!