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  • Posted: Jun 15, 2022
    Deadline: Not specified
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  • Alpha-Pharma has a commitment to mankind, a commitment of improving the quality of life for each and every individual through which we constantly strive to innovate, improve and increase the availability of cost-efficient generic medicines to the global market. We believe that medicine should be available to all people regardless of their location, and affo...
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    Regulatory Affairs Officer

    Alpha Pharmacy Limited is recruiting for the position of a REGULATORY AFFAIRS OFFICER.

    REQUIREMENTS.

    • B.Pharm.  
    • Minimum of 3 years of work experience as a regulatory officer.
    • Should be familiar with agencies' compliance processes.

    JOB DESCRIPTION.

     

    • Product registration with NAFDAC, renewals, import permits, clearing permits (for Narcotics), Laboratory analysis requests, facility inspection requests, and product dossiers review.
    • Obtaining permits for orphan products with NAFDAC under service drugs provisions; global listing licenses for food and cosmetics products.
    • Pharmacovigilance (safety issues about our product. Collection of product ADRs and logging into pharmacovigilance logbook that is reported to NAFDAC.
    • Monthly reconciliation report for each product we market which will be returned to the affected companies and NAFDAC Pharmacovigilance centre.
    • Postmarketing surveillance – any additional information besides pharmacovigilance issues that concerns our product. E.g emergence of better molecules. New indications for existing products. New formulations such as incrementally modified drugs.
    • Narcotic and controlled substances distribution monitoring and reporting.
    • Monitoring of cold chain and temperature-controlled logistics systems.
    • Interfacing with regulatory teams of the company’s foreign trade partners under the supervision of the regulatory affairs manager.

    Method of Application

    Interested and qualified candidates should forward their CV to: hradmin@alphapharmacyltd.com using the position as subject of email.

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