Regulatory Affairs Senior Officer

About the role

MS Pharma is seeking a Regulatory Affairs Senior Officer to lead the preparation, submission, and lifecycle management of pharmaceutical products in Saudi Arabia and the GCC. You will ensure compliance with SFDA regulations and support the company’s growth across the region.

Key responsibilities

• Prepare and submit Marketing Authorization Applications (MAAs), variations, renewals, pricing files, and labeling updates through SFDA portals.
• Compile, validate, and publish eCTD sequences using SFDA‑approved software.
• Respond to SFDA inquiries, deficiency letters, and follow‑up requests.
• Maintain regulatory databases and monitor submission timelines.
• Coordinate with QA, QC, supply chain, manufacturing, and packaging teams to gather dossier inputs.

Required profile

• Strong knowledge of SFDA guidelines and GCC regulatory systems.
• Experience with eCTD, track‑and‑trace, pricing portals, and ERP/DR systems.
• Excellent planning, organization, and attention to detail.
• Effective communication and negotiation skills with authorities.
• Ability to manage multiple submissions in parallel.

Required skills

• eCTD compilation and validation
• SFDA submission platforms
• Regulatory databases management
• ERP and GCC DR systems
• CTD formatting
• GMP‑related regulatory knowledge

What we offer

• Opportunity to work in a leading regional pharmaceutical organization.
• Continuous learning and professional development.
• Collaboration with experienced cross‑functional teams.
• Career growth within an international company.