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    Senior Regulatory affairs pharmacist - Johannesburg, South Africa - Curiska

    Curiska
    Curiska Johannesburg, South Africa

    Found in: Executive Placements ZA C2 - 5 days ago

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    Description

    JOB OVERVIEW:
    Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements.


    DUTIES AND RESPONSIBILITIES:

    • Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist

    • Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.

    • Provide input to the regulatory strategy in-line with business objectives

    • Detailed understanding of regulatory guidelines and technical requirements

    • Manage and implement safety updates where required

    • Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations

    • To ensure approval and compliance of printed packaging material and promotional marketing material.

    • License renewals with service providers i.e. SAHPRA, South African Pharmacy Council (SAPC)

    • Writing and developing of SOP in line with Global SOP's

    • Manage internal and external audits (i.e.Global & SAHPRA)

    • Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation

    • Manage of product complaints and deviations

    • Managing and maintaining regulatory documentation filing system.

    • Ensuring regulatory compliance and quality related records are available and retained.

    • Co-ordinate product recall or market withdrawal when necessary

    • Obtain and distribute updated information on domestic and international laws

    • Report ADR to Global Safety and SAHPRA

    • Follow-up of Adverse Drug Reactions (ADRs),

    • Pharmacovigilance training of local staff

    • Answering of requests from the Regulatory Authority with co-operation with Global Safety

    MINIMUM REQUIREMENTS:

    • Education:
    o B. Pharm (Bachelor of pharmacy)
    o Registration with the South African Pharmacy Council (SAPC)


    • Job Training and Experience:
    o Minimum 5 years' experience in Regulatory Affairs – (must have human medicine experience and biologicals)
    o Experience in Product registration (NCE)
    o Maintenance of dossiers and updating thereof
    o Pharmacovigilance experience / knowledge of collecting and reporting
    o Knowledge of SAHPRA submission portals
    o Launch procedures for new products
    o Knowledgeable and experience regarding QA processes, APQRs, customer complaints etc.
    o In depth knowledge of Regulations, Acts and Guidelines for South Africa and East Africa pertaining to dossier submissions and life cycle management.
    o Knowledge of the Marketing Code


    • Systems knowledge
    o Microsoft office suite including Word, Excel, Power Point at an Intermediate level.
    o Familiar with ZAZIBONA processes
    o Competent and experienced in eCTD submissions.

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