Regulatory Affairs Officer

Job title : Regulatory Affairs Officer

Job Summary

• We are seeking experienced and highly knowledgeable Regulatory Affairs Officers to manage regulatory compliance and product registration activities within our organization.

Responsibilities
Product Registration and Dossier Management:

• Prepare, review, and coordinate regulatory submissions for new pharmaceutical products.
• Manage product registration, renewal, variation, and post-approval applications.
• Prepare and review Common Technical Document (CTD) dossiers and supporting documents.
• Ensure accuracy, completeness, and consistency of regulatory submissions.
• Coordinate responses to regulatory queries and deficiency letters.
• Maintain product registration status and regulatory submission trackers.

Regulatory Authority Liaison:

• Act as the primary contact between the company and regulatory authorities.
• Coordinate regulatory inspections, meetings, and product-related communications.
• Maintain professional communication with regulatory agencies.

Requirements

• Bachelor's degree in Pharmacy, Industrial Chemistry or allied disciplines.
• Minimum of three (3) to five (5)years of relevant experience in Regulatory Affairs, preferably within Nigeria.
• Proven experience managing NAFDAC product registrations, renewals, variations, and regulatory submissions.
• Strong knowledge of NAFDAC guidelines, SON standards, and other applicable Nigerian regulatory frameworks.
• Experience in a supervisory or managerial regulatory affairs position in a pharmaceutical manufacturing environment is preferred.
• A Master's degree or relevant postgraduate qualification is an advantage.