وظيفة أخصائي شؤون تنظيمية للأدوية (صيدلي) شاغرة لدى شركة متعدد في الرياض

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/eCTD) 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/eCTD 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.