Senior Regulatory Specialist
Location: Johannesburg, South Africa
Responsible for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements.
Key Responsibilities:
- Experience in EC and RA submission, including initial submission and protocol amendments submission.
- Independently preparing submissions to both EC and RA.
- ICF preparation using templates.
- Skilled knowledge of local regulatory environment, submissions, and approval processes.
- IMP supplies management at the local level.
- Validation of translated documents.
As a Senior Regulatory Affairs and Compliance Specialist, you will play a crucial role in overseeing regulatory submissions, ensuring compliance with all applicable laws and regulations, and providing expert guidance on regulatory matters.
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