Salma Sameh

Background

About Salma Sameh

With over 13 years of experience in Regulatory Affairs, I have built a strong track record in regulatory strategy development, product registrations, renewals, and compliance management across diverse pharmaceutical portfolios. My expertise spans local and international regulatory landscapes, enabling seamless interactions with Ministries of Health, global regulatory teams, and cross-functional stakeholders to drive product approvals and successful market entries. I am passionate about ensuring regulatory excellence while aligning strategies with business objectives to accelerate innovation and compliance. Currently serving as a Regulatory Affairs Lead & Scientific Office Manager at Sanofi Gulf, I drive regulatory strategies for the Middle East, overseeing product lifecycle management, risk mitigation, external engagement, and market access. I have successfully led complex regulatory submissions, streamlined Standard Operating Procedures (SOPs), and ensured compliance during audits and inspections. Additionally, my leadership in cross-functional collaboration fosters synergy between Regulatory, Medical, Quality, and Supply Chain teams to enable seamless execution of strategic initiatives. Beyond regulatory operations, I have a proven ability to lead high-impact projects. As a Project Lead across AMET (Africa, Middle East, and Turkey), I have spearheaded regulatory initiatives that enhance business efficiency, and accelerate product launches. My ability to navigate complex regulatory environments and proactively address challenges has positioned me as a trusted strategic partner within the pharmaceutical industry. Previously, at MPC Pharma, I managed regulatory affairs for a diverse pharmaceutical portfolio, including AstraZeneca, Abbott, Novartis, Takeda, and BMS, ensuring compliance, market access, and seamless new product registrations. My contributions to regulatory system advancements were recognized when I played a key role and contrition in MOH system. Earlier in my career, I gained valuable experience in regulatory submissions, approvals, and new product launches at Nycomed (now Takeda), Wedjat Pharma, and Holdipharma. I am eager to collaborate, innovate, and shape regulatory frameworks that drive business success. A firm believer in continuous learning and professional growth.