Senior Regulatory SpecialistLocation: Johannesburg, South AfricaResponsible 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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