On-site Full Time
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Saudi , Jeddah
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Motaded Consultancy شركة متعدد

Job Details

Company: Motaded Consultancy (شركة متعدد) — Riyadh | Full-time, On-site About the Role Motaded is launching a Pharmaceutical & Medical Products Regulatory Consulting division to support clients in registering and maintaining their medicinal products with the Saudi Food and Drug Authority (SFDA). We are seeking a licensed pharmacist with regulatory affairs expertise to lead client submissions and compliance — this is a regulatory consulting role, not a dispensing pharmacy role. Key Responsibilities Prepare, review, and submit drug registration dossiers (CTD/e CTD) to the SFDA through the Saudi Drug Registration (SDR) platform. Conduct gap analysis of clients' global dossiers against SFDA country-specific requirements (Module 1, Arabic labeling, stability data, etc.). Manage SFDA correspondence, respond to deficiency letters, and follow submissions through to Marketing Authorization. Support clients as/through the Authorized Local Agent for foreign manufacturers, including agency-agreement and MOC-registration coordination. Handle post-marketing obligations: variations, renewals, transfers, and pharmacovigilance coordination (QPPV support). Advise clients on registration pathways (Verification / Abridged), classification, and pricing-file requirements. Prepare and maintain SOPs and ensure compliance with SFDA regulations, GMP/PIC-S, and ICH/GCC-DR guidelines. Qualifications Bachelor's degree or higher in Pharmacy / Pharmaceutical Sciences from an accredited institution. Licensed/registered with the Saudi Commission for Health Specialties (SCFHS). Knowledge of SFDA drug registration requirements, CTD/e CTD dossiers, and ICH/GCC-DR guidelines. Experience in regulatory affairs, drug registration, or a scientific/regulatory office in Saudi Arabia or the Gulf (preferred). Familiarity with pharmacovigilance and post-marketing obligations (an advantage). Strong attention to detail, accurate documentation, and SOP adherence. Professional English; Arabic is a strong advantage (SFDA labeling and correspondence require Arabic). Ability to work on-site in Riyadh within a multidisciplinary team.

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About Motaded Consultancy شركة متعدد
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