• Application Deadline: Sun, 10 Dec 2023 00:00:00 GMT
• Position: Regulatory Affairs Officer


• Job Type Full Time


• Qualification BA/BSc/HND


• Experience 0 - 3 years


• Location Lagos


• Job Field Law / Legal 
  

Description 

• Our client is a dedicated pharmaceutical company 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 preparing and submitting 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 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.

Requirements

•  Interested candidates should possess a Bachelor's Degree in relevant fields with 0 - 3 years work experience.