Regulatory Affairs Officer In A Reputable Pharmaceutical/FMCG Company

⏲ Feb 18, 2021, 5:55 PM
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Adexen Recruitment Agency - Our client in the Pharmaceutical / FMCG industry is currently recruiting suitably qualified candidates to fill the position below:

Job Title: Regulatory Affairs Officer

Location: Lagos
Job Type: Full Time

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.