• Application Deadline:
• Position: Assistant Manager, Regulatory Affairs



• Job Type Full Time



• Qualification BA/BSc/HND , MBA/MSc/MA



• Experience 5 years



• Location Lagos




• Job Field Pharmaceutical 
  
  

Job Description

• We seeking an experienced and highly knowledgeable Regulatory Affairs Manager to lead regulatory compliance and product registration activities within our organization.


• Product Registration and Dossier Management:


• Prepare, review, and coordinate regulatory submissions for new pharmaceutical products.


• Manage product registration, renewal, variation, and post-approval applications.


• Preparation 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.


• A Master's Degree or relevant postgraduate qualification is an advantage


• Minimum of 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 environmentis preferred.