Shama Munim
About Shama Munim
Shama Munim serves as the Director of Regulatory Affairs at Fortress Biotech, where she has worked since 2019. With a background in regulatory affairs and pharmaceutical sciences, she has held various positions in the industry, including roles at Teva Pharmaceuticals and significant contributions to drug development and commercialization efforts.
Work at Fortress Biotech
Shama Munim has been serving as the Director of Regulatory Affairs at Fortress Biotech since 2019. In this role, she oversees regulatory strategies and compliance for the company's product development initiatives. Prior to her current position, she worked as the Manager of Regulatory Affairs at Fortress Biotech from 2018 to 2019. Her experience in the Greater New York City Area has contributed to her expertise in navigating complex regulatory landscapes.
Previous Experience at Teva Pharmaceuticals
Before joining Fortress Biotech, Shama Munim held several positions at Teva Pharmaceuticals. She worked as a Program Manager for Neurodegenerative Diseases from 2016 to 2018, where she managed projects related to drug development in this therapeutic area. Additionally, she served as a Senior Regulatory Affairs Associate for CNS, Oncology, Pain, and Migraine from 2015 to 2016. Her career at Teva began with an internship in Formulations in 2013.
Education and Expertise
Shama Munim earned a Master of Science (MS) in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, completing her studies from 2013 to 2015. She also holds a Bachelor of Science (BS) in Pharmaceutical Sciences from the Massachusetts College of Pharmacy and Health Sciences, where she studied from 2009 to 2013. Her educational background provides her with a solid foundation in regulatory practices and pharmaceutical sciences.
Research Contributions
Shama Munim has co-authored abstracts for professional organizations such as the American Academy of Pediatrics and the American College of Medical Genetics. Her contributions to research highlight her involvement in the scientific community and her commitment to advancing knowledge in the field of regulatory affairs.
Key Projects and Initiatives
Shama Munim played a significant role in various projects during her career. She was involved in the development and asset purchase agreement with Sentynl Therapeutics for commercialization at Cyprium Therapeutics. Additionally, she contributed to the IND approval process for MB-102 (CD123 CAR T) targeting acute myeloid leukemia and related conditions at Mustang Bio. Furthermore, she was part of the acquisition of Caelum Biosciences by AstraZeneca’s Alexion Pharmaceuticals.