
Regulatory Affairs Expert
3 semanas atrás
Job Overview
We are seeking an experienced professional to join our team as a Regulatory Specialist. In this role, you will be responsible for maintaining awareness of regulatory legislation, guidance, and practice in assigned countries.
Main Responsibilities:
- You will collect and organize data and information required by regulatory authorities.
- 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 as applicable.
- Evaluate start-up and maintenance activities to ensure they meet client expectations and comply with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.
Qualifications:
- A university/college degree in a life science or related allied health profession from an accredited institution is preferred.
- Minimum 3 years of experience in clinical development or start-up/regulatory process.
Benefits:
This role offers a unique opportunity to work in a dynamic environment and develop your skills in regulatory affairs.
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