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Geneith Manufacturing
Pharmaceuticals & Biotechnology
Regulatory Affairs Officers
Mid level
On-site
Ogun
Full-time
Published
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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.
- 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.
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