Regulatory Advisor
EU Regulatory Expert
Dr. Siddharth Chachad is a seasoned executive with over 20 years of leadership experience in Research and Development (R&D), Translational Medicine, Global Clinical Development, Pharmacovigilance (PV), and Medical Affairs. He has a proven track record in successfully developing and filing a wide range of drug products, including differentiated formulations, novel chemical entities (NCEs), biologics, complex generics, biosimilars, and vaccines in global markets. Dr. Chachad has served as a qualified person for pharmacovigilance (EU QPPV), overseeing the PV system and fulfilling PV obligations, and has led more than 100 GCP and GVP audits worldwide. Throughout his career, Dr. Chachad has held prominent roles, including Executive Vice President and Head of Global Clinical Management at Dr. Reddy’s Laboratories, Global Head of Clinical Development and Medical Affairs at ELC Group, and Head of Global Clinical Development at Cipla.
His early career included positions at Lupin Pharmaceuticals and Roche, where he honed his skills in medical affairs, clinical development, and medical writing. Dr. Chachad’s expertise encompasses strategic product development, translational research, global regulatory submissions, and clinical evaluation of medical devices, particularly in key therapeutic areas such as respiratory medicine, oncology, immunology, neurology, and dermatology. He has a strong focus on patient-centricity and the development of new products for orphan drug indications, leveraging innovation in digital analytics and clinico-regulatory affairs to enhance productivity and quality while optimizing costs.In addition to his professional roles, Dr. Chachad is an active member of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), an Affiliate Member of the Faculty of Pharmaceutical Medicine in the UK, and a core committee member of the European Medical Writers Association (EMWA).