Drug Regulatory Affairs Specialist (Pharmacist) SFDA📣 إعلان

About Motaded Consultancy

Motaded Consultancy is establishing a new Pharmaceutical & Medical Products Regulatory Consulting division. This division aims to provide essential support to clients in registering and maintaining their medicinal products with the Saudi Food and Drug Authority (SFDA). We are seeking a dedicated professional to join our team in Riyadh, Saudi Arabia, for a full-time position.

The Role of a Drug Regulatory Affairs Specialist

This role is focused on regulatory consulting, specifically for pharmaceutical and medical products, and is distinct from a dispensing pharmacy role. The Drug Regulatory Affairs Specialist will lead client submissions and ensure compliance with SFDA regulations. We are looking for a licensed pharmacist with 0-1 years of regulatory affairs expertise to fill this position.

Key Responsibilities

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

Qualifications and Requirements

• Must be licensed and registered with the Saudi Commission for Health Specialties (SCFHS).
• A licensed pharmacist with 0-1 years of experience in regulatory affairs.

Work Environment

This position requires the ability to work on-site in Riyadh as part of a multidisciplinary team, contributing to a collaborative and dynamic consulting environment.

Application Process

Candidates who meet the specified qualifications are encouraged to apply.