
Senior Regulatory Compliance Expert
2 semanas atrás
Our Senior Regulatory Specialist will be the primary contact with investigative sites during site start-up activities and maintenance. They will be responsible for collecting the required investigator and essential documents to ensure timely submission to EC/IRB/Third body/Regulatory Authority and that documentation meets applicable regulations and sponsor specifications.
Responsibilities- Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
- Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority.
- Compile and prepare routine submissions filed to IRB/IEC/Third body/Regulatory Authorities.
- Liaise with internal and external vendors in the generation of Regulatory Authority submissions.
- Perform a review of final submission documents.
- Ensure all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget, and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
- Prevent and escalate study issues appropriately and in a timely fashion.
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution, AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
- Familiarity with investigator start-up documents and contract/budget negotiation process; previous interaction with operational project teams and investigative sites.
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
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