Country Regulatory Specialist
1 semana atrás
Job Summary
Thermo Fisher Scientific is seeking a highly skilled Country Regulatory Specialist to join our team. As a key member of our regulatory team, you will be responsible for preparing, reviewing, and coordinating local regulatory submissions in alignment with our global submission strategy.
Key Responsibilities
- Regulatory Submission Coordination
- Prepare, review, and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.
- Regulatory Strategy Advice
- Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
- Project Coordination
- Provide project specific local SIA services and coordination of these projects.
- Communication and Collaboration
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Process Alignment
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
- Performance Metrics
- Achieves PPD's target cycle times for site.
- Regulatory Compliance
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- Country-Specific Documents
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- Feasibility Activities
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
- Database Management
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
- Country Study Files
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
- Knowledge and Compliance
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
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