Regulatory Affairs & QA Coordinator at Sunbeth Global Concepts (SGC)

The Regulatory Affairs & QA Coordinator at Sunbeth Healthcare an associate company of Sunbeth Global Concepts is responsible for Coordinating regulatory affairs, quality assurance, and documentation activities, ensuring NAFDAC, NAPAMS, and PCN compliance, accurate submissions, timely approvals, effective quality control, and regulatory readiness across product registrations.

Job Details

• 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.

Requirements

• 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