Regulatory Affairs Pharmacist - Midrand - Emporium Human Capital

    Emporium Human Capital
    Emporium Human Capital Midrand

    2 days ago

    Emporium Human Capital background
    Description

    Regulatory Affairs Pharmacist (CAM)

    We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team in Midrand. The successful candidate will have a strong background in regulatory affairs, preferably in human medicines, including complementary medicines and medical devices.

    Key Responsibilities:

    • Manage work streams for- and report on assigned portfolio of products
    • Internal product queries from relevant departments
    • External product queries from SAHPRA, other MRAs and third-party stakeholders
    • Establish regulatory priorities and allocate resources and workloads
    • Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness or compliance with regulatory standards

    Requirements:

    • Bachelor's Degree in Pharmacy
    • Diploma in Pharmacy and Registration with the South African Pharmacy Council
    • +5 years experience in Regulatory Affairs
    • Demonstrable experience across product development, commercialization and maintenance lifecycle
    • Sound project management capabilities
    • Proven ability to consistently deliver to quality, time and cost standards

    Desirable Skills:

    • Experience in use of CTD software builder and compilation of eCTD dossier applications
    • IT skills including Microsoft Office
    • Ability to prioritise and work to tight deadlines
    • Systems and operations analysis
    • Basic cost management skills
    Company Values:
    • Responsibility
    • Excellence
    • Collaboration


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