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    • Regulatory Affairs Pharmacist - Johannesburg - Emporium

    Emporium
    Emporium Johannesburg

    1 week ago

    Default job background
    Description

    Regulatory Affairs Pharmacist (OTC)

    Fulfil a critical role in ensuring the regulatory compliance of our pharmaceutical products, working closely with cross-functional teams to bring new and existing products to market.

    About the Role:

    We are seeking an experienced Regulatory Affairs Pharmacist to join our team in Midrand. The ideal candidate will have a strong background in human medicines, including complementary medicines and medical devices, and experience in end-to-end regulatory activities.

    Key Responsibilities:

    1. Manage work streams for assigned portfolios of products and report on progress
    2. Respond to internal product queries from relevant departments and external product queries from SAHPRA, other MRA's, and third-party stakeholders
    3. Establish regulatory priorities, allocate resources, and workload, ensuring timely submission of materials to regulatory agencies
    4. Develop regulatory strategies and implementation plans for new products, focusing on complementary medicines and medical devices
    5. Conduct dossier due diligence to address data gaps, prepare dossiers for call-up and registration, and maintain existing registrations according to legislation, regulations, and guidelines
    6. Prepare registration applications for submission to regulatory authorities and collaborate with internal and external stakeholders to assess regulator's submissions requirements
    7. Update and maintain databases, trackers, and systems for all regulatory-related activities and ensure Good Regulatory Practices are maintained
    8. Maintain current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry
    9. Internal training and mentoring of peers when required and establish effective relationships with Regulatory Authorities, internal, and external stakeholders
    10. Formulate or implement regulatory affairs systems, policies, and procedures to ensure regulatory compliance is maintained or enhanced
    11. Support activities such as internal audits or regulatory agency inspections and ensure alignment of personal and company values

    Core Competencies:

    1. Experience in using CTD software builder and compiling eCTD dossier applications
    2. IT skills, including Microsoft Office, ability to prioritise, and work under tight deadlines
    3. Systems and operations analysis, basic cost management skills, active learning, strategic thinking, and ability to cope with complexity and change
    4. Cross-functional skills, including networking, liaising, and negotiating with others, setting standards and objectives, and monitoring progress
    5. Complex problem-solving and decision-making skills, customer relationships, development of people, responsibility, excellence, collaboration, and alignment with Company values
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