Senior Regulatory Specialist - Johannesburg - Tampa Gardens Senior Living

    Tampa Gardens Senior Living
    Tampa Gardens Senior Living Johannesburg

    3 days ago

    Default job background
    Description

    Senior Regulatory Specialist

    Oversee regulatory compliance and performance in assigned protocols, adhering to ICH/GCP and country regulations, client policies, quality standards, and adverse event reporting requirements.

    Key Responsibilities:

    • Submit EC and RA documents, including initial submissions and protocol amendments.
    • Prepare independent submissions to both EC and RA.
    • Create Investigator's Brochures using standardized templates.
    • Demonstrate expertise in local regulatory environments, submission processes, and approval procedures.
    • Manage IMP supplies at the local level.
    • Verify translated documents for accuracy.

    This role entails guiding the regulatory affairs team, ensuring compliance with laws and regulations, and providing expert advice on regulatory matters.

    Job Description:

    The Senior Regulatory Affairs and Compliance Specialist will play a pivotal role in overseeing the preparation and submission of regulatory documents, ensuring adherence to relevant laws and regulations, and offering authoritative guidance on regulatory issues.

    Responsibilities:

    The responsibilities of this position include preparing and submitting documents to regulatory authorities, managing IMP supplies, verifying translated documents, and demonstrating expertise in local regulatory environments.

    Requirements:

    To be successful in this role, you will need to have experience in regulatory affairs, a strong understanding of local regulatory environments, and excellent communication skills.

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Senior regulatory specialist