Rima Bawarshi Nassar is a global regulatory affairs executive with over 30 years of experience in international pharmaceutical and biotech companies. She has a proven record of sound regulatory strategy design and execution, successful drug submissions, approvals and health agency interactions, and effective assessment and evaluation of external opportunities. Rima has a strong understanding and knowledge of the pharma and biotech industry and drug research and development. Throughout her career, she has demonstrated outstanding leadership and management skills.
During her career, Rima has held several leadership positions of increasing responsibilities at various pharma and biotech companies. She spent 5 ½ years at Genmab as vice president and head of the global regulatory affairs group where she was responsible for leading and managing the group across multiple regions and sub-functions (strategy, CMC, labeling/intelligence, operations, ad/promo).
At Genmab, Rima built an outstanding regulatory team with top talent and skill set. She oversaw the approval of two BLAs: Tivdak® (tisotumab vedotin) for cervical cancer in collaboration with SeaGen and Epkinly™ (epcoritamab) for diffuse large B cell lymphoma in collaboration with AbbVie. She also served on the Board of Directors of Genmab from 2019-2021 (elected by the US employees). After retiring from Genmab in 2023, Rima established a pharma consulting company – RBN Pharma Consulting LLC – to provide strategic regulatory services to pharma and biotech companies across various phases of drug development, therapy areas, and regions.
Prior to Genmab, Rima spent 11 years at Sanofi in various leadership roles. She established and led a new regulatory unit at Sanofi – Regulatory Business Development- to lead and manage potential in-licensing/out-licensing opportunities (ranging from pre-clinical to post- marketing) across all Global Business Units, therapeutic areas, and regions. She also served as the US Deputy Head for Global Regulatory Affairs/Research and Development group and the Global Diabetes Group Head. In this role, she oversaw the approval of Adlyxin (lixenatide), ORIGIN efficacy supplement for Lantus, Apidra® SoloStar, and in-licensing of Afrezza® (inhaled insulin from Mannkind). She also represented Sanofi at several FDA/PhRMA meetings for cardiovascular risk assessment in diabetes drug development. Rima has sound knowledge of device development and human factors/usability studies. Prior to Sanofi, Rima worked for 7 years at Novo Nordisk where she was the US regulatory leader for the inhaled insulin program and the women’s healthcare products. She oversaw the approval of a lower dose of Activella® and the development of a lower dose of Vagifem®.
Rima holds a Ph.D. in Pharmaceutical Sciences from the University of Kentucky and a B.S. in Pharmacy with distinction from the American University of Beirut. She also completed a post-doctoral fellowship at the University of Kentucky working on the formulation of anti-neoplastic drugs under a grant from the National Cancer Institute, resulting in the lyophilized dosage form of carboplatin (Paraplatin®). Rima holds four patents in nasal delivery of drugs (including Stadol® Nasal Spray) and is the author of several publications.