Nimi (Mantej) Chhina serves as Executive Director, Head of Global R&D and Regulatory Policy at BioMarin Pharmaceutical Inc. In addition, she currently co-chairs the US Regulatory Advisory Group of the Alliance for Regenerative Medicine (ARM). Previously, she served as vice-chair for ARM’s US Regulatory Affairs Committee, as co-chair for BIO’s Regenerative Medicines Committee and BIO’s Orphan Drug and Rare Disease Committee. She co-chaired the Food and Drug Law Institute’s (FDLI) 2023 Annual conference and served on the 2023 BIO global annual convention planning committee. She served on planning committee for FDLI’s 2020 regenerative medicines conference. She is well-published and has taught the community and presented on topics relevant for cell and gene therapy. For example, in 2021, she presented in APEC education series for LATAM health authorities on unique clinical and nonclinical considerations for cell and gene therapy development. Also, she spoke as panelist on sessions on cell and gene therapy regulation at FDLI annual conferences in 2022 and 2023.
Nimi joined BioMarin in 2017 as Director, leading US Regulatory Policy. Prior to joining BioMarin, Nimi spent 7 years at the US Food and Drug Administration (FDA), where she served in multiple roles including as team lead in the Division of Medical Policy Development in the Center for Drug Evaluation and Research (CDER).
Nimi received her MS (honors school) in human genetics from Guru Nanak Dev University in India; PhD in biotechnology and functional genomics from George Mason University, VA (USA); and JD from University of the District of Columbia David A. Clarke School of Law (USA). Also, she has received the Regulatory Affairs Certification (RAC) as well as a certificate in legislative affairs from the Government Affairs Institute at the Georgetown University, DC (USA).
Nimi is based in the Washington, DC area, and is actively engaged on the R&D and regulatory policy development landscape. In her personal life, she loves traveling and spending quality time with her family.