Dr. Samar Roshdy is a Regulatory Affairs professional with over 25 years of experience in regulatory strategy, compliance, and health authority engagement across pharmaceuticals, vaccines, medical devices, and consumer health products. Based in Cairo, she currently serves as Senior Regulatory Affairs Manager at GSK, where she leads regulatory operations for vaccines.

Dr. Samar holds a Bachelor of Pharmacy (1998)and a Diploma in Industrial Pharmacy from Cairo University. Her career began with a decade of diverse roles, including research at the Egyptian National Center for Research, serving as a Health Authority member in inspection and registration, and working as a Regulatory Associate at ALCON. She also gained broad experience through freelance regulatory work, managing Registration , importation and release of cosmetics, food supplements, and feed additives.

For the past 15 years at GSK, Samar has been instrumental in shaping regulatory pathways for vaccines. She played a pivotal role in navigating Egypt’s 2010 regulatory shift that separated biological products from pharmaceuticals, successfully registering vaccines under the new biological health authority framework. Her expertise spans innovative product registration, license maintenance, and the use of reliance pathways for Vx and Rx registration. She is also adept at managing variations through both standard and fast-track processes.

Known for her strategic thinking, collaborative leadership, and commitment to regulatory excellence, Samar continues to mentor colleagues and contribute to advancing regulatory practices that support innovation and patient access.

She is a dedicated professional, a wife, and a proud mother of three daughters.