Anuja has more than 10 years of regulatory experience at FDA’s Center for Drug Evaluation and Research (CDER) as a Designated Federal Official (DFO) for Division of Advisory Committee and Consultant Management (DACCM) and Tobacco Product Science Advisory Committee (TPSAC) at Center for Tobacco Products (CTP), Office of Science (OS), and as a Regulatory Affairs Expert and Team Leader in the Office Oncologic Diseases (OOD), Division of Oncology 2 (DO2). Anuja also has more than 5 years of combined experience in pharmaceutical drug development as a clinical trials study coordinator, pharmaceutical professional representative for bone health and allergy drugs, and as a Senior Project Manager at a Contract Research Organization. 

Anuja has significant expertise in US regulatory affairs, given her extensive experience working at the Food and Drug Administration. During her stay at the FDA from 2009 to 2020, Anuja took multiple leadership positions including Designated Federal Official (DFO), Health Science Administrator, Senior Regulatory Affairs Expert, and Team Leader.

When she was the DFO for Division of Advisory Committee and Consultant Management (DACCM), she was responsible for the administrative and scientific review of Investigational New Drug Application (IND), New Drug Application (NDA), licensing or other health science issues presented to advisory committee members for detailed review, including a high profile joint meeting to discuss the occurrence of suicidality in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder and other psychiatric disorders which led to development of guidance and new regulations.

After she became Oncology Regulatory Affairs Expert, she independently managed more than 150 active INDs daily per 21 CFR 312s, and served as a member of CDER’s Regulatory Operations Advisory Board that consisted of Division Directors, CPMS, and Senior RPMs.

In addition, Anuja participated in the development of FDA Draft Guidance Document entitled, “Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics” which provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers.

Furthermore, she oversaw the implementation of the Federal Advisory Committee Act on the establishment and activities of the Tobacco Product Scientific Advisory Committee (TPSAC) during her time as the DFO and Health Science Administrator at the Center for Tobacco Products (CTP), Office of Science (OS).

Anuja holds a Master of Public Health in Epidemiology at the George Washington University, and a Graduate Certificate in Patient and Product Safety from the University of Southern California. She obtained her bachelor’s degree in Food Science and Human Nutrition from the University of Florida. Her hobbies include traveling, event coordinating, and spending time with her family on hiking trails.