Assistant Manager, Regulatory Affairs At Zamiva Transnational Services

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.