Regulatory Affairs Officers
About This Role About the role Geneith Manufacturing is seeking Regulatory Affairs Officers to support regulatory compliance and pharmaceutical product-registration activities in its Mowe, Ogun State operations. Key responsibilities
Prepare and coordinate regulatory submissions for new pharmaceutical products. Manage product registrations, renewals, variations, and post-approval applications. Prepare and review Common Technical Document dossiers and supporting records. Check submissions for accuracy, completeness, and consistency. Coordinate responses to regulatory queries and deficiency letters. Maintain product-registration records and submission trackers. Serve as a liaison with Nigerian regulatory authorities. Coordinate regulatory inspections, meetings, and product communications. Maintain professional communication with regulatory agencies.
Requirements
Bachelor's degree in Pharmacy, Industrial Chemistry, or an allied discipline. Three to five years of relevant regulatory-affairs experience, preferably in Nigeria. Demonstrated experience with NAFDAC registrations, renewals, variations, and submissions. Strong knowledge of NAFDAC guidelines, SON standards, and applicable Nigerian regulations. Experience in pharmaceutical manufacturing is preferred. Supervisory or managerial regulatory-affairs experience is an advantage. A master's degree or relevant postgraduate qualification is an advantage. Preference may be given to candidates living around Mowe, neighbouring Lagos areas, or willing to relocate.
<