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    Regulatory Affairs Pharmacist - Johannesburg, South Africa - MNA Recruitment

    MNA Recruitment
    MNA Recruitment Johannesburg, South Africa

    1 week ago

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    Description

    A global pharmaceutical company has a vacancy for a Regulatory Affairs Pharmacist to co-ordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.

    Key Responsibilities:

    • Keeping abreast of regulatory requirements in Central, East Africa and Mauritius countries.
    • Ensure the completion of submissions/ variations according to Central, East Africa and Mauritius strategic plan and timelines.
    • Drive registration/variation follow up strategies and find solutions to potential supply challenges.
    • Ensure that labelling for Central, East Africa and Mauritius is complaint with in-country specific requirements.
    • Ensure master product tracker is up to date and accurate at all times. Ensure alignment to all other trackers that are linked to the master.
    • Conduct Due diligence activities
    • Co-ordinate and compile documentation for submission in Central, East Africa and Mauritius countries (New submissions/variations/RA documents) where required.
    • Liaise and communicate with and support local agent in each country to meet regulatory requirements and timelines.
    • Liaise and communicate with QA, Supply Chain and PV departments to ensure compliance and alignment with the various functions (including samples ordered for renewals, variations, and new submissions).
    • Respond to product-specific queries from Central, East Africa and Mauritius countries where required.
    • Co-ordinate internal back up and filing (electronic and hard copy) of dossiers and relevant communication.
    • Download information from external portal i.e. Docubridge, sharepoint, we-transfer or regulatory drive.
    • Arrange for translations of overseas documentation if required.
    • Schedule Microsoft team meetings or teleconferences as needed.
    • Conduct training sessions with Central, East Africa and Mauritius Team to ensure quality submissions in line with guidelines and upskilling of team members.
    • Standardize folder structures and save information on NRD - Central, East Africa and Mauritius folder.
    • Liaise with principals or the company with regards to outstanding information.
    • Verify documents for completeness and current information.
    • Compile and maintain spreadsheets and status reports as needed and upon request.
    • Compilation of work map trackers to ensure visibility of tasks.
    • Ensure Central, East Africa and Mauritius registrations are renewed in a timeous manner and retention fees are paid as required.
    • Assist with task risk management and compilation of risk plans when associated with submissions.
    • Ensure the completion of all assigned Company training within the specified timelines.
    • Forward all received Product Quality Complaints, Adverse Events and Medical Enquiries to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs

    Requirements

    • Must have a completed Bachelor of Pharmacy Degree and/or equivalent.
    • 3-5 years' experience in pharmaceutical industry (Regulatory Affairs/ Quality/ Production).
    • Should have a sound knowledge of Sub-Saharan countries regulatory requirements and guidelines.
    • Must have experience and understanding of electronic document management systems / eCTD.
    • High level Computer literacy.
    • People skills – highly adapted interpersonal skills.
    • Problem solving analysis skills.
    • Priority setting – initiative and follow through.
    • Time management and ability to self-motivate.
    • Strong attention to detail.
    • Ability to work under pressure.
    • Embodies Values & Behaviours in all internal and external interactions
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