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  • Posted: Sep 26, 2023
    Deadline: Oct 10, 2023
  • Never pay for any CBT, test or assessment as part of any recruitment process. When in doubt, contact us

    UnoCasa Limited was incorporated in 2009 to provide companies with business solutions in Marketing, Business Strategy , Recruitment and general Human Resources consultancy.
    Read more about this company


    Regulatory Affairs Officer

    Job Description

    • Our client is seeking a Regulatory Affairs Officer to ensure full compliance with regulatory requirements and provide crucial support in the planning and coordination of regulatory activities.

    Key Responsibilities

    • Gather information and documents for new product registrations, formula changes, and variations in existing products. Submit these to NAFDAC and other relevant authorities for approval.
    • Monitor product registrations and ensure timely renewal of existing product approvals.
    • Compile product dossiers received from manufacturers in formats acceptable to regulatory agencies.
    • Assist in the preparation and submission of regulatory agency applications, reports, and correspondence.
    • Contribute to the development of regulatory strategies and implementation plans for new product submissions.
    • Handle online applications for API permits, Excipient permits, Narcotic permits, and other relevant permits in the single trade portal.
    • Support in coordinating and monitoring clinical studies of the company’s products.
    • Keep other company departments informed about regulatory requirements.
    • Ensure timely submissions and approvals of applications according to regulatory plans and strategies.
    • Review marketing materials, information leaflets, and packaging artworks to meet regulatory agency requirements.
    • Ensure regulatory compliance in advertisements and secure approval for planned promotional materials.
    • Communicate regulatory issues with the Regulatory Affairs Manager and other related departments, formulating appropriate responses.
    • Assist in activities such as audits, regulatory agency inspections, and product recalls.
    • Assist in coordinating the destruction of expired and rejected products and materials.
    • Document reported Adverse Drug Reactions and enforce pharmacovigilance compliance related to assigned products.
    • Support documentation efforts to ensure compliance with domestic and international regulations and standards.
    • Register company premises, Superintendent Pharmacist, and key Organizational Managers with the Pharmacists Council of Nigeria (PCN).
    • Represent the department in QMS and cGMP activities.
    • Coordinate QMS and cGMP documentation, implementation, and audit-related activities within the department.
    • Disseminate information on QMS and cGMP implementation to department staff.
    • Complete Corrective Action and Preventive Action Plans for gaps identified during inspections and ensure their closure.
    • Provide assistance to external auditors in compliance reviews.
    • Participate in internal audits, contribute to report writing, and make presentations at monthly meetings as needed.


    • Candidates should possess a Bachelor's Degree qualification with at least 3 years work experience.

    Method of Application

    Interested and qualified? Go to UNOCASA Limited on to apply

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