Regulatory Affairs Senior Officer📣 إعلان

About MS Pharma

MS Pharma is a leading pharmaceutical company specializing in the development, manufacturing, and distribution of generic and biosimilar medicines. Founded in 1989, with headquarters in Amman, Jordan, and a Corporate Management Office in Zug, Switzerland, MS Pharma operates across 12 countries with more than 2,000 employees. The company serves patients throughout the Middle East, North Africa, and sub-Saharan Africa, guided by its Triple T values: Take Charge, Together for Better, and Thrive.

The Role of Regulatory Affairs Senior Officer

MS Pharma is seeking a Regulatory Affairs Senior Officer to join its team in Riyadh, Saudi Arabia. This full-time position is responsible for executing regulatory strategies and managing lifecycle activities for pharmaceutical products within Saudi Arabia and the GCC region. The Senior Officer supports the preparation and submission of Marketing Authorization Applications (MAAs), handles variations, renewals, pricing files, and labeling updates, ensuring full compliance with SFDA requirements, including eCTD compilation and validation.

Key Responsibilities

• Prepare and submit Marketing Authorization Applications (MAAs), lifecycle management dossiers (variations, renewals), pricing applications, and labeling updates via SFDA systems.
• Prepare, compile, validate, and submit electronic Common Technical Document (eCTD) sequences using SFDA-approved publishing software.
• Ensure accuracy, format compliance, and readiness of eCTD submissions as per SFDA guidelines.
• Respond to SFDA inquiries, deficiency letters, and follow-up requirements.
• Maintain and update regulatory databases and track submission timelines.
• Coordinate cross-functionally with QA, QC, supply chain, manufacturing, and packaging for dossier inputs and labeling implementation.
• Execute regulatory commitments to avoid product shortages and align supply chain approvals.
• Support regional and global regulatory initiatives and projects.

Qualifications and Experience

• A Bachelor’s Degree in Pharmacy is mandatory, with preference for a Saudi Pharmacist.
• A minimum of 5 to 10 years of relevant experience in regulatory affairs is required for this role.

Work Type and Location

This is a full-time position based in Riyadh, Saudi Arabia. The role operates within a dynamic pharmaceutical company environment, contributing to product availability and regulatory compliance across the Middle East, North Africa, and sub-Saharan Africa regions.

Join MS Pharma

Candidates who meet the specified qualifications and experience are invited to apply and contribute to MS Pharma's mission of serving patients with essential medicines.