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Regulatory Affairs Officer

Adexen

Lagos, Nigeria

Job description

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.
We thank all applicants however only those selected will be contacted.

Industry

FMCG

Job Seniority

Mid level

Job Category

Legal & Administrative

Employment Type

Full time

Experience

3 - 5 years

Skills

Compliance, Policy, Process Control, Process Improvement, Quality System, Quality Auditing, Regulatory Affairs, Regulation Management

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