Regulatory Affairs Officer at UNOCASA Limited

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.

Requirements

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