Dr. Sarah McMullen is the Country Director for the FDA India Office. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned over 20 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. The last nine years of her experience has focused on international arenas including import operations and foreign office service. Dr. McMullen has a Doctor of Philosophy in inorganic chemistry and a Bachelor of Science in chemistry from Emory University.

Greg is the new Deputy Director for the India Office. He joined FDA’s India Office in 2022 as an International Relations Specialist focusing on the Drugs portfolio. Previously, Greg directed CDER’s Special Projects Staff - a multi-disciplinary staff working on mission-critical scientific, regulatory, legislative, and operational projects. Greg joined FDA in 2011 as a CVM Project Manager serving as the primary liaison on the drug approval process for sponsors and review teams. Prior to the FDA, Greg managed various aspects of Phase I-IV clinical trials for global CROs.

Mr. Dhruv Shah is a Public Health Specialist with the FDA India office. Prior to joining FDA, Dhruv worked with major Pharmaceutical R&Ds. He brings around 10 years of experience in formulation development of solid oral drug products for US, EU and other regulated markets. His domain expertise includes product development using Quality by Design (QbD) concepts, process development, optimization, scale up, validation and technology transfer. Dhruv holds a Master of Pharmacy degree with specialization in Pharmaceutical Technology & Pharmaceutics.

Dr. Jacquin (Jackie) Jones is an International Relations Specialist. She has worked as a program lead and consumer safety officer in the Office of Compounding Quality and Compliance, policy lead and project manager in the Office of Policy for Pharmaceutical Quality, and project manager for drug applications in CDER. Dr. Jones’ career has encompassed work in public health, regulatory compliance, policy development and implementation, clinical research, stakeholder engagement, training, and leadership. She holds a Doctor of Health Sciences with a Global Health concentration, a Master of Science in Nursing Informatics (Sigma Thea Tau), and a Bachelor of Science in Nursing.

Dr. (Phil) Nguyen joined the India office in 2022 as an International Relations Specialist. He previously served as a Medical Officer/BIMO reviewer in CDER’s Office of Scientific Investigations (OSI). Outside of FDA, Dr. Nguyen has over 10 years of experience across clinical, nonprofit, and global health policy spaces in the Asia Pacific as a Director of research and advocacy initiatives on innovation, AMR, supply chain, regulatory systems strengthening, and pharmaceutical standards in International Public Policy and Regulatory Affairs at the US Pharmacopeia. Dr. Nguyen holds a medical doctorate from Tufts University, and a bachelor’s in Molecular & Cell Biology, cum laude, from Harvard University.

Dr. Sudheendra is the Senior Technical Advisor for drugs. Prior to joining FDA India Office, Sudheendra worked for a Contract Research Organization as Head – Quality Assurance [GCP]. Sudheendra has about 20 years of experience in Clinical Research, Quality Assurance, and Quality Management Systems. He has audited more than 450 Bioequivalence Studies and audits of different therapeutic drugs. He also has exposure to different regulatory agencies. Sudheendra holds a Ph.D. in Biochemistry from Gulbarga University, Karnataka.

Peter received a Ph.D. in analytical chemistry from the University of Kansas in 1991. He has over 15 years in pharmaceutical development experience from both the NDA and ANDA side, as well as 15 years at the FDA supporting generic drug quality review across a wide range of therapeutic areas. He has been involved in important FDA initiatives like the PEPFAR program for prioritizing AIDS drugs for developing countries, as well as the current KASA initiative for structured drug product assessment.

Sarah Ibrahim is the Associate Director for Stakeholder and Global Engagement in the OGD/ CDER at the U.S. Food and Drug Administration (FDA). Dr. Ibrahim develops OGD strategies to address identified and emerging regulatory challenges in relation to the international nature of the generic drug industry. She established OGD’s current global affairs program, the generic drug cluster which is the first generic drug forum that involves the word leading regulatory agencies. In collaboration with other CDER and FDA offices, she supports stakeholder engagement concerning issues related to globalization of the generic pharmaceutical supply and harmonization of regulatory approaches for generic drugs.

Ms. Aditi S. Thakur, currently is working as a senior pharmaceutical quality assessor at the FDA/CDER/OPQ/OPMA. She has experience in performing the risk-based assessment of manufacturing process and controls for characterization and manufacturing of drug substances and drug products in role of a primary and secondary assessor. She has been involved in providing scientific and regulatory advice and guidance concerning assessment of the manufacturing facilities, manufacturing process and controls submitted in regulatory submissions; international and domestic facilities inspections; data integrity audits; FDA guidance/policies and current regulatory practices.

Sharmista Chatterjee is currently the Division Director in Division of Pharmaceutical Manufacturing II, within FDA’s Office of Pharmaceutical Manufacturing Assessment (OPMA), in CDER, FDA. She has been with the FDA since 2006. During her tenure she has been actively involved in many agency initiatives that include Quality by Design efforts, FDA-EMA QbD pilot program, KASA, NIR guidance, Continuous Manufacturing, and in the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) . She has served in many roles of increasing responsibility including serving as the CMC Lead for QbD (Quality by Design) in the Office of New Drug Quality Assessment (ONDQA) and as the technical lead for the FDA-EMA QbD pilot.

Utpal M. Munshi, Ph.D., currently leads a team of scientists responsible for the regulatory assessment of the bioequivalence section of Abbreviated New Drug Applications (ANDA) and other stakeholder submissions. In addition, Dr. Munshi has contributed to the development and implementation of Agency guidances and has led multiple teams in the assessment of complex generic drug products and other challenging regulatory science issues. Dr. Munshi received his Ph.D. in Biological Chemistry from the University of Michigan and then undertook post-doctoral training at the National Cancer Institute in Frederick, Maryland before joining DBI in 2007.