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  • Senior Regulatory Specialist - Johannesburg - Tampa Gardens Senior Living

    Tampa Gardens Senior Living
    Tampa Gardens Senior Living Johannesburg

    1 month ago

    Default job background
    Description

    Senior Regulatory Specialist - FSP (Johannesburg)

    This role involves working in a hybrid office-based environment, with a focus on performance and compliance with assigned protocols.

    Key responsibilities include ensuring adherence to ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting requirements both internally and externally.

    Essential Experience:

    1. Submission experience in EC and RA, including XML completion, initial submission, and protocol amendments.
    2. Preparing submissions to both EC and RA, with support from the CTC for document collection.
    3. ICF preparation using templates.
    4. In-depth knowledge of the local regulatory environment, submissions, and approval processes, and understanding of their impact on study start-ups.
    5. Management of IMP supplies at the local level, including vendors providing standard of care medications.
    6. Validation of translated documents.

    We offer competitive financial rewards, comprehensive training, and development opportunities. Our team values work-life balance and prioritizes employee welfare alongside patient care.


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