Nihal Hamdalla is a Regulatory, Quality, and Pharmacovigilance leader with over 22 years of experience in the pharmaceutical industry, including more than 15 years of dedicated regulatory expertise across the Middle East and Africa region. Currently serving as Technical Director – MEA Region at Exeltis Middle East FZLLC, she leads a multidisciplinary team responsible for Regulatory Affairs, Quality Management, Pharmacovigilance, and Supply Chain operations across key markets including Saudi Arabia, UAE, the Gulf states, Iraq, Egypt, and Levant.

A founding member of the Exeltis MEA leadership team since 2016, Nihal played an instrumental role in establishing the company’s regional infrastructure from the ground up – developing local SOPs, Quality Management Systems, and Pharmacovigilance frameworks fully aligned with international and local regulatory standards. Her regulatory portfolio spans over 210 registered SKUs across generics, innovative, and locally manufactured products.

Currently, Nihal is spearheading a landmark pharmaceutical facility establishment project in the Kingdom of Saudi Arabia – navigating the regulatory, quality, and operational complexities of building compliant manufacturing capabilities in one of the region’s most strategically significant healthcare markets. This initiative reflects her broad expertise at the intersection of regulatory strategy, quality assurance, and operational execution.

Prior to Exeltis, Nihal built a distinguished track record at Bayer Middle East FZLLC where she managed regulatory affairs across the Gulf Cooperation Council countries.
Nihal is a recognised thought leader in the regional regulatory landscape, regularly representing her organisation before Health Authorities and actively engaging with industry policy discussions.

Holding a B.Sc. in Pharmacy (with Honours) from Cairo University and an Executive Programme in Business from IESE Business School (Madrid), Nihal brings a rare combination of scientific rigour, strategic vision, and hands-on operational leadership to every role she undertakes. Her passion for regulatory excellence and her ability to build high-performing cross-functional teams make her a highly respected voice in the industry.