Regulatory Affairs Pharmacist - Gauteng - MNA Recruitment

    MNA Recruitment
    MNA Recruitment Gauteng

    1 week ago

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    Description

    Regulatory Affairs Pharmacist

    A global pharmaceutical company seeks a Regulatory Affairs Pharmacist to coordinate, project control and provide regulatory support for Central, East Africa and Mauritius countries.

    Duties Responsibilities

    • Maintain awareness of regulatory requirements in Central, East Africa and Mauritius countries ensuring timely compliance.
    • Coordinate submission/variation completion according to regional strategic plans and timelines.
    • Develop registration/variation follow up strategies and resolve potential supply challenges.
    • Ensure labeling compliance with in-country specific requirements for Central, East Africa and Mauritius.
    • Maintain accuracy and alignment of master product trackers and linked trackers at all times.
    • Conduct due diligence activities as required.
    • Compile documentation for submissions in Central, East Africa and Mauritius countries (new submissions/variations/RA documents) as needed.
    • Liaise with local agents in each country to meet regulatory requirements and timelines.
    • Collaborate with QA, Supply Chain and PV departments to ensure compliance and alignment.
    • Respond to product-specific queries from Central, East Africa and Mauritius countries as required.
    • Maintain internal backup and filing systems for dossiers and relevant communication.
    • Download information from external portals and share with teams as necessary.
    • Arrange translations of overseas documentation if required.
    • Schedule Microsoft team meetings or teleconferences as needed.
    • Provide training sessions to ensure quality submissions in line with guidelines and upskilling of team members.
    • Standardize folder structures and save information on NRD folders.
    • Liaise with principals or the company regarding outstanding information.
    • Verify documents for completeness and current information.
    • Compile and maintain spreadsheets and status reports as needed.
    • Maintain work map trackers to ensure task visibility.
    • Ensure timely renewal of Central, East Africa and Mauritius registrations and payment of retention fees as required.
    • Assist with task risk management and compilation of risk plans associated with submissions.
    • Complete all assigned Company training within specified timelines.
    • Forward received Product Quality Complaints, Adverse Events and Medical Enquiries to relevant personnel in Quality Assurance/Pharmacovigilance/Medical Affairs.

    Qualifying Requirements

    • Bachelor of Pharmacy Degree and/or equivalent.
    • 3-5 years' experience in pharmaceutical industry (Regulatory Affairs/Quality/Production).
    • Sound knowledge of Sub-Saharan countries regulatory requirements and guidelines.
    • 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 self-motivation.
    • Strong attention to detail.
    • Ability to work under pressure.
    • Embodies values and behaviours in all internal and external interactions.

    Candidates meeting criteria may submit applications via this portal or www.mnarecruitment.com. No feedback within 7 days indicates unsuccessful application.

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