Regulatory Affairs Senior Officer

Regulatory Affairs Senior Officer – Drive Compliance and Strategic Growth in the GCC Pharmaceutical Landscape

Join MS Pharma, a dynamic and innovative leader in the pharmaceutical industry, as a Regulatory Affairs Senior Officer. With a legacy spanning over three decades, MS Pharma specializes in the development, manufacturing, and distribution of high-quality generic and biosimilar medicines, serving patients across the Middle East, North Africa, and sub-Saharan Africa. As part of our mission to enhance healthcare accessibility, we are seeking a highly skilled professional to spearhead regulatory strategies, ensure seamless product lifecycle management, and maintain unwavering compliance with regional and global standards.

At MS Pharma, we foster a culture defined by our Triple T values: Take Charge, Together for Better, and Thrive. These principles guide our collaborative approach, empowering teams to lead with accountability, drive innovation, and deliver exceptional results. This role offers a unique opportunity to contribute to a thriving organization that values professional growth, cross-functional collaboration, and a commitment to excellence.

Key Responsibilities

As the Regulatory Affairs Senior Officer, you will play a pivotal role in ensuring that our pharmaceutical products meet the highest regulatory standards while supporting their successful market introduction and lifecycle management. Your responsibilities will include:

• Strategic Regulatory Compliance: Lead the preparation and submission of Marketing Authorization Applications (MAAs), lifecycle management dossiers (including variations, renewals, and pricing applications), and labeling updates through the SFDA systems in Saudi Arabia and across the GCC.
• Electronic Documentation Excellence: Compile, validate, and submit eCTD sequences using SFDA-approved publishing software, ensuring strict adherence to formatting and submission guidelines to accelerate approval timelines.
• Stakeholder Engagement: Act as the primary liaison with regulatory authorities, addressing inquiries, deficiency letters, and follow-up requirements with precision and professionalism.
• Cross-Functional Collaboration: Coordinate seamlessly with QA, QC, supply chain, manufacturing, and packaging teams to gather critical dossier inputs and ensure smooth labeling implementation.
• Regulatory Risk Mitigation: Execute regulatory commitments to prevent product shortages and align supply chain approvals, safeguarding operational continuity.
• Innovation and Process Improvement: Support regional and global regulatory initiatives, contributing to the evolution of best practices and driving continuous improvement in compliance processes.
• Database Management: Maintain and update regulatory databases, tracking submission timelines and ensuring transparency across all stakeholders.

Why This Role Matters

Your expertise will directly impact the market access, patient safety, and operational efficiency of MS Pharma’s portfolio. By ensuring compliance with evolving regulatory landscapes, you will help us maintain our reputation as a trusted partner in the pharmaceutical industry while contributing to meaningful advancements in healthcare delivery.

Qualifications and Experience

To excel in this dynamic role, you must possess:

• Education: A Bachelor’s Degree in Pharmacy (with Saudi Pharmacist certification) is mandatory.
• Experience: 2–4 years of hands-on experience in regulatory affairs within the pharmaceutical sector, specifically in Saudi Arabia or the GCC, with a proven track record in:
• Handling MAAs, variations, renewals, pricing applications, and SFDA liaisons.
• Preparing and validating eCTD sequences using SFDA-approved platforms (e.g., Extedo, LORENZ docuBridge).
• Ensuring compliance with GCC DR, ERP, and CTD formats, as well as GMP-related regulatory requirements.
• Managing product localization and technology transfer documentation effectively.
• Technical Proficiency: Proficiency in MS Office (Excel, Word, PowerPoint) and a deep understanding of:
• SFDA guidelines and regulatory systems, including eCTD, track-and-trace, and pricing portals.
• Regulatory procedures for new drug applications, variations, renewals, and pricing in the Kingdom of Saudi Arabia.
• Soft Skills: Exceptional planning, organizational, and leadership abilities, coupled with:
• Attention to detail and accuracy in high-stakes regulatory documentation.
• Strong communication and negotiation skills to engage with authorities and cross-functional teams.
• Proven problem-solving and decision-making capabilities in fast-paced environments.
• Ability to manage multiple submissions in parallel while maintaining rigorous documentation and follow-up discipline.
• Language: Fluent Arabic (native proficiency) and fluent English (spoken and written) are essential for effective collaboration and stakeholder engagement.

Join Us in Shaping the Future of Pharmaceutical Compliance

If you are a detail-oriented, proactive professional passionate about regulatory excellence and career growth within a diverse, international organization, we invite you to be part of MS Pharma’s journey. Embrace the opportunity to work in a supportive, inclusive environment that values innovation, ownership, and continuous learning. Your expertise will not only drive compliance but also empower us to deliver impactful healthcare solutions across the region.

Location: Riyadh, Saudi Arabia.