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  • Senior Regulatory Affairs Pharmacist Complimentary - Johannesburg - Emporium

    Emporium
    Emporium Johannesburg

    2 weeks ago

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    Description

    Senior Regulatory Affairs Pharmacist Complimentary Medicine

    We are seeking a highly experienced Senior Regulatory Affairs Pharmacist to join our team in Midrand. This role requires a strong background in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices.

    Key Responsibilities:

    • Manage work streams for assigned portfolio of products and report on progress.
    • Respond to internal and external product queries from relevant departments and stakeholders.
    • Establish regulatory priorities and allocate resources and workloads.
    • Review regulatory agency submissions to ensure timelines, accuracy, and compliance with standards.
    • Coordinate and submit new product applications in South Africa and other territories.

    Requirements:

    • Bachelor's Degree in Pharmacy and Registration with the South African Pharmacy Council.
    • Minimum 5 years' experience in Regulatory Affairs, preferably in human medicines.
    • Demonstrable experience across the product development lifecycle.
    • Sound project management capabilities.
    • Proven ability to deliver to quality, time, and cost standards.

    Core Competencies:

    • Experience with CTD software builder and eCTD dossier applications.
    • IT skills, including Microsoft Office.
    • Ability to prioritize and work to tight deadlines.
    • Systems analysis and problem-solving skills.

    What We Offer:

    • A dynamic and collaborative work environment.
    • Ongoing professional development opportunities.
    • A competitive salary package.

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