
Country Regulatory Expert
1 dia atrás
Job Overview
The Country Regulatory Expert plays a pivotal role in ensuring seamless regulatory submissions across various markets.
Key Responsibilities:
- Prepare and review local regulatory submissions, including therapy approvals, viral safety dossiers, and import licenses
- Collaborate with internal clients to provide strategic advice on local regulatory requirements
- Coordinate project-specific services to align with submission activities and mutually agreed-upon timelines
- Ensure submission processes are aligned to the critical path for site activation
- Work towards achieving target cycle times for site activation
- Develop country-specific Patient Information Sheet/Informed Consent form documents
Requirements
- Strong understanding of local regulatory frameworks and procedures
- Excellent communication and project management skills
- Ability to work independently and as part of a team
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