Regulatory Affairs Supervisor – Pharmaceutical (Riyadh)

About the role

The Regulatory Affairs Supervisor – Pharmaceutical will lead the pharmaceutical registration team in Riyadh, overseeing the full SFDA drug registration lifecycle from pre‑submission strategy through approval and post‑approval maintenance. This full‑time, on‑site position ensures compliance with Saudi regulatory requirements and supports clients across the MENA region.

Key responsibilities

• Supervise and mentor the pharmaceutical registration team, assign workloads, review submissions and ensure quality and SLA compliance.
• Lead new drug registration submissions to the SFDA via the SDR portal, preparing and reviewing dossiers in eCTD/CTD format.
• Manage product lifecycle activities including renewals, variations and post‑approval commitments.
• Act as the primary point of contact with the SFDA, responding to queries and deficiency letters within deadlines.
• Advise international clients on Saudi regulatory strategy, requirements, timelines and pricing submissions.
• Monitor SFDA regulations, guidelines and circulars and communicate changes internally and to clients.
• Oversee pharmacovigilance activities such as adverse event/ICSR reporting, PSUR/PBRER submissions, risk‑management plans and safety variations.
• Support or act as the local Qualified Person for Pharmacovigilance (QPPV/LQPPV) liaison with the SFDA’s National Pharmacovigilance Center.
• Support GMP clearance, CPP/legalisation requirements and coordinate with manufacturers’ regulatory affairs teams.
• Maintain accurate registration trackers and report department KPIs.

Required profile

• Proven experience in pharmaceutical regulatory affairs, preferably with SFDA submissions.
• Demonstrated ability to supervise and develop a registration team.
• Strong knowledge of Saudi regulatory guidelines, GMP requirements and pharmacovigilance obligations.
• Excellent coordination skills with cross‑functional teams and external authorities.
• Ability to monitor regulatory changes and provide timely guidance to stakeholders.

Required skills

• SFDA SDR portal submission
• eCTD/CTD dossier preparation
• Pharmacovigilance (adverse event reporting, ICSR, PSUR, PBRER)
• Risk‑management plan development
• GMP clearance and CPP/legalisation processes