Drug Regulatory Affairs Specialist (Pharmacist) – SFDA

About the role

Motaded Consultancy is launching a Pharmaceutical & Medical Products Regulatory Consulting division to assist clients in registering and maintaining medicinal products with the Saudi Food and Drug Authority (SFDA). We are looking for a licensed pharmacist with strong regulatory affairs expertise to lead client submissions, ensure compliance, and act as a key liaison with the SFDA. This position is a consulting role, not a dispensing pharmacy job, and will be based on‑site in Riyadh.

Key responsibilities

• Prepare, review and submit drug registration dossiers (CTD/eCTD) via the Saudi Drug Registration (SDR) platform.
• Conduct gap analyses of global dossiers against SFDA‑specific requirements, including Module 1, Arabic labeling and stability data.
• Manage SFDA correspondence, address deficiency letters and follow submissions through to Marketing Authorization.
• Support foreign manufacturers as the Authorized Local Agent, coordinating agency agreements and MOC registrations.
• Handle post‑marketing obligations such as variations, renewals, transfers and pharmacovigilance coordination (QPPV support).
• Advise clients on registration pathways, product classification and pricing‑file requirements.
• Develop and maintain SOPs, ensuring compliance with SFDA regulations, GMP/PIC‑S and ICH/GCC‑DR guidelines.

Required profile

• Bachelor’s degree or higher in Pharmacy or Pharmaceutical Sciences from an accredited institution.
• Licensed/registered with the Saudi Commission for Health Specialties (SCFHS).
• In‑depth knowledge of SFDA drug registration requirements, CTD/eCTD dossiers and ICH/GCC‑DR guidelines.
• Experience in regulatory affairs or drug registration in Saudi Arabia or the Gulf (preferred).
• Familiarity with pharmacovigilance and post‑marketing obligations (advantage).
• Professional English; Arabic proficiency is a strong advantage.
• Ability to work on‑site in Riyadh within a multidisciplinary team.

Required skills

• CTD/eCTD dossier preparation
• SFDA SDR platform navigation
• GMP compliance
• ICH/GCC‑DR guideline application
• Pharmacovigilance coordination