Enter a job title or keyword
Regulatory Affairs & QA Coordinator
Job Location:
Monthly Salary:
Posted:
21 August 2026 (Yesterday)
Posted:
Application Deadline:
18 November 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
- Portals and tracker: Establish and manage the NAPAMS accounts and regulator relationships.
- Device filings: Assemble quality-check and file IMDRF-format technical files for Sunbeth Healthcare.
- Medicines filings: Support CTD dossier assembly with the regulatory consultant manage dossier screening.
- Review management: Track NAFDAC review clocks per SKU chase progress through documented channels and manage query responses to zero-defect resubmission within five working days.
- Document control: Establish the document management system and master register for Sunbeth Healthcare covering every regulatory document per SKU with ownership status and expiry tracking; verify every incoming manufacturer document against issuing authority product scope validity window and legalization requirements.
- Authentication pipeline: Track each document through notarization and embassy legalization with the shared channel flagging bottlenecks before they touch a filing date.
- Samples and labels: Coordinate sample import permits laboratory submissions and results and label compliance per SKU for both regimes.
- SONCAP and PCN: Coordinate the SONCAP PC1 certification programme for the device lines and prepare the PCN premises packs with the Superintendent Pharmacists tracking renewals thereafter.
- SOPs and renewals: Draft and maintain the SOPs supporting premises licensing document handling and pharmacovigilance readiness; run the expiry calendar so no document or registration lapses including the 5-year renewal horizon.
- Reporting: Maintain the regulatory calendar against the Program Schedule and report weekly to the Program Manager with a per-SKU status dashboard.
- Degree in pharmacy life sciences or a related field.
- Regulatory affairs certification (e.g. RAC) and quality management training (ISO 9001 or GDP/GMP awareness) are advantages
- 4 years Nigerian regulatory affairs experience covering NAFDAC product registration end to end with hands-on NAPAMS portal experience.
- Demonstrable document control track record including notarization embassy legalization or apostille workflows.
- Working knowledge of the NAFDAC tariff and current registration guidelines; PCN familiarity.
- Experience with both medical device and medicine files is a strong advantage as is experience with reliance-route applications for SRA-approved products
Required Experience:
IC
About Company
Sunbeth Global Concepts is a global agro-commodities sourcing and trading company empowering farmers and creating socio-economic impact through strategic partnerships, innovation, and industry expertise.
