Rahul Jangle

Background

About Rahul Jangle

With over 13 years of experience in the biologics drug product domain, I specialize in biosimilars and novel formulations of monoclonal antibodies (mAbs) and other biologics (Insulins). As Lead Formulation Development Biologics group at BioGenomics Ltd, my role emphasizes formulation innovation, process characterization, risk assessment, Technology transfer, MSAT, Regulatory CMC CTD sections drafting/reviewing and regulatory compliance for global markets, including USFDA, EMA, and MOW. My contributions include supporting large-scale manufacturing and leading teams in delivering cutting-edge drug products for biologics. My work is defined by a commitment to advancing biopharmaceuticals through collaboration, technical expertise, and problem-solving. Proficient in CMC regulatory, MSAT, and drug product development (QbD) & its analysis and tech transfer strategies, I aim to bridge science and compliance while meeting patient needs. By leveraging insights from past leadership roles, I continue to drive impactful solutions for the Biologics products development, regulatory filings and commercialization of biologic drug products.