Regulatory Affairs Senior Officer

About MS PharmaMS 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 serving patients throughout the Middle East, North Africa, and sub-Saharan Africa.Our CultureAt MS Pharma, we are guided by our Triple T values: Take Charge, leading with accountability and courage; Together for Better, collaborating with trust and respect; and Thrive, driving innovation, growth, and continuous improvement. These values shape the way we work, make decisions, and contribute to our collective success every day.Why Join MS Pharma? Opportunity to work in a leading regional pharmaceutical organization. Continuous learning and professional development opportunities. Collaboration with experienced cross-functional teams and industry experts. Career growth opportunities within a diverse international organization. A culture that encourages innovation, ownership, and continuous improvement.Job SummaryThis role is responsible for executing regulatory strategies and managing lifecycle activities for pharmaceutical products in Saudi Arabia and the GCC. The Senior Officer supports the preparation and submission of Marketing Authorization Applications (MAAs), handles variations, renewals, pricing files, labeling updates, and ensures compliance with SFDA requirements, including eCTD compilation and validation.Professional Knowledge & Main Competencies SFDA guidelines and regulatory systems (eCTD, track-and-trace, pricing portal) GCC DR, ERP, and CTD formats Pharmaceutical manufacturing and GMP-related regulatory requirements Regulatory procedures for new drug applications, variations, renewals, and pricing in KSA Familiarity with product localization and technology transfer documentation Strong planning and organizational skills Attention to detail and accuracy Effective leadership and team supervision Excellent communication and negotiation skills with authorities Problem-solving and decision-making capabilities Ability to manage multiple submissions in parallel Strong documentation and follow-up disciplineDuties And Responsibilities (But Not Limited To)Prepare and submit 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.EducationJob Requirements:Bachelor’s Degree in Pharmacy (Saudi Pharmacist) – MandatoryExperience 2–4 years in regulatory affairs within pharmaceuticals in Saudi Arabia/GCC. Proven experience handling MAAs, variations, renewals, pricing, and SFDA liaison. Hands-on experience in preparing and validating eCTD sequences using SFDA-approved publishing platforms (e.g., Extedo, LORENZ docuBridge, etc.). Strong MS Office skills (Excel, Word, PowerPoint).LanguageArabic – NativeEnglish – Fluent (spoken and written)Job Location: Riyadh, Saudi Arabia.At MS Pharma, we believe that diverse perspectives drive innovation and better outcomes. We are committed to creating an inclusive workplace where every employee feels valued, respected, and empowered to contribute. We welcome applications from qualified candidates regardless of gender, age, disability, ethnicity, religion, or background. We believe great leadership starts with leading yourself, empowering others, and creating lasting business impact. Through our Leadership Model, we foster a culture of accountability, collaboration, continuous growth, and innovation.Be part of our exciting journey andapply now!