
Regulatory Operations Specialist
4 days ago
Key Responsibilities:
- Develop and execute regulatory strategies to manage operational activities across assigned regions.
- Contribute to the development of the global regulatory strategy, providing input into the Regulatory Functional Plan (RFP) and Seed Document.
- Collaborate with regional teams to ensure alignment on regulatory strategies and implement RFPs effectively.
- Determine requirements and set objectives for interactions with Health Authorities (HAs).
- Facilitate the preparation and finalization of briefing books and contribute to the creation of summary documents.
- Develop and implement plans for timely responses to HA requests and coordinate responses accordingly.
- Maintain collaboration with stakeholders and ensure adherence to regulatory compliance standards.
Requirements:
- Minimum 5+ years of experience in Regulatory Affairs is required.
- The ideal candidate should be able to produce high-quality strategic project documentation and presentations.
- Deliver reliable, timely, and accurate information about project-specific issues within own department and to key stakeholders.
- Ability to maintain regulatory documentation following established guidelines and meet regulatory requirements.
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