Dr Harle holds a Ph.D. in Pharmaceutical Sciences from Nagpur University (RTM Nagpur University) and a Master of Science in Pharmacy. In addition, he has earned Post-Graduate Diplomas in Business Management and Marketing Management from IGNOU.
He brings nearly 24 years of experience in the global biopharmaceutical industry, including more than 18 years in biologics and biosimilars and over 14 years in leadership roles spanning research and development, clinical development, regulatory affairs, manufacturing, commercialization, and business management.
Before joining Shilpa Biologicals, Dr Harle served as Chief Business Officer at Artemis Medicare Services Limited and Premedium Pharma (Apollo Group). Earlier, he held leadership positions as Assistant Vice President and Global Head – Clinical Development at Amneal Group/Kashiv Biosciences, Global Head – Clinical Development at Abbott, and Associate Director and R&D Head at Ferring Pharmaceuticals. He has also worked with Bharat Serums & Vaccines, Sun Pharma, and several other pharmaceutical companies.
According to the company, Dr Harle possesses expertise across the entire biologics value chain, including portfolio strategy, research and development, chemistry, manufacturing and controls (CMC), clinical development, regulatory approvals, manufacturing, commercialization, CDMO partnerships, and P&L management. His experience covers biosimilars, novel biologics, peptides, recombinant proteins, cell therapies, including CAR-T, and medical devices.
Dr Harle also has extensive experience working with global regulatory agencies, including the USFDA, EMA, MHRA, Health Canada, and CDSCO. During his career, he has contributed to the development of more than 10 biosimilars and over five novel biologics, including multiple Investigational New Drug (IND) and Biologics License Application (BLA) submissions. He has authored around 40 scientific publications, published two books, holds two patents, and has received several industry awards recognizing his contributions to biopharmaceutical research and development.
According to Shilpa Medicare Limited, the appointment became effective on August 3, 2026, as part of the company's senior management changes and statutory disclosures made to the stock exchanges.
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