Regulatory Affairs Specialist
hace 4 semanas
The Regulatory Manager plays a critical role in ensuring the compliance of clinical trials with applicable regulations. This includes providing regulatory strategy and development guidance, coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, and maintaining a current knowledge of regulations and guidance documents.
Key Responsibilities:- Provides regulatory guidance throughout the clinical development life cycle
- Compiles, coordinates, and reviews applications to Regulatory Authorities
- Develops and/or reviews documents intended for submission to Regulatory Authorities and/or Ethics Committees
- Represents Global Regulatory Affairs at project team meetings
- Maintains project plans, project trackers, and regulatory intelligence tools
- Strong knowledge of regulations and guidance documents
- Excellent communication and project management skills
- Ability to work independently and as part of a team
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Regulatory Affairs Specialist
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