Adexen Regulatory Affairs Officer Jobs in Nigeria

Adexen Regulatory Affairs Officer Jobs in Nigeria


Job Introduction

  • Adexen is mandated by one of its clients in the Pharmaceutical/FMCG industry to recruit a Regulatory Affairs Officer. The position is based in Lagos, Nigeria.

    Responsibilities

  • To ensure that the company is in full compliance with regulatory requirements and to support in Planning and coordination of regulatory activities.

  • Assembling of information and documents for new products registration, as well as formula changes and variations in existing products, and submission to NAFDAC and other relevant authorities for approval.

  • Tracking of product Registration and ensure timeliness of renewal of existing Products.

  • Compilation of product Dossiers received from Manufacturers in formats acceptable by the regulatory agency.

  • Preparation and submission of regulatory agency applications, reports, or correspondence.

  • Assist in developing regulatory strategies and implementation plans for the preparation and submission of new products.

  • Online Application for API permits, Excipient permits, Narcotic permits, and other relevant permits in the single trade portal.

  • Timely enrolment of all product certificates in the single trade portal.

  • Assist in the coordination and monitoring of Clinical Studies of the Company’s products.

  • To keep other departments in the company updated on regulatory requirements.

  • Ensure timely submissions and approvals of applications according to regulatory plan and strategy, ensuring continuity of supply and regulatory compliance.

  • Review materials such as detailing materials, information leaflets and packaging artworks to ensure that regulatory agency requirements are met.

  • Ensuring regulatory compliance in adverts and getting approval on planned promotional materials.

  • Communicating regulatory issues with the Regulatory Affairs Manager and other related departments and formulating appropriate responses.

  • Assist in activities such as audits, regulatory agency inspections, or product recalls.

  • Assist in Coordination of destruction of expired and rejected products and materials.

  • Documentation of reported Adverse Drug Reaction and Enforcement / Pharmacovigilance as regards faking or any other issues relating to assigned products.

  • Assist in documentation efforts to ensure compliance with domestic and international regulations and standards.

  • Registration of company premises, Supt. Pharmacist and key Managers with the Pharmacists Council of Nigeria, PCN. OTHER
    DUTIES QMS & cGMP RESPONSIBILITIES (ISO 9001, NAFDAC, WHO & OTHERS).

  • Represent the department on QMS and cGMP activities.

  • Coordinate QMS and cGMP documentation, implementation & audit-related activities in the department.

  • Disseminate information on QMS and cGMP implementation to other staff in the department.

  • Identify QMS and cGMP improvement issues in the department and bring such up for the management representative’s consideration.

  • Complete Corrective Action and Preventive Action Plan for gaps (non-conformances) picked in the department during any inspection and ensure closeout of such.

  • Provide adequate assistance to external auditors in compliance reviews.

  • Participate in all internal audits, report writing, and presentations at the monthly meetings as the need arises.

  • Any other assignment as delegated by the Regulatory Affairs Manager.

    Desired Skills and Experience

  • Bachelor's Degree in Pharmacy.

  • Minimum 3 years of Regulatory Experience in the industry.

  • Good working knowledge of Regulations and current industry practices.

  • Management skills: team building, decision-maker, leadership and communication.

  • Experience in production, quality and safety processes.

  • Good knowledge GMP rules, QMSs and Regulatory guidelines.

    How to Apply

  • For more information and job application details, see; Adexen Regulatory Affairs Officer Jobs in Nigeria


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