Mridula Shukla

Bio:

Mridula is a seasoned Regulatory Affairs Leader with over 15 years of experience guiding pharmaceutical and biotechnology products from early-stage development to global commercialization. She specializes in Immuno-Oncology, Gene and Cell Therapy, Metabolic conditions, and Ophthalmology. Her career spans leading biopharma companies, including Roche and Regeneron, where she has successfully led cross-functional regulatory efforts—from IND and CTA submissions to NDA, BLA, and MAA filings, including securing expedited and special designations from US and Global Health Authorities. She has also worked in collaboration with major pharma partnerships, contributing to the successful advancement of assets, including blockbuster exits.   
 
A recognized thought leader, Mridula has contributed to industry standards, including authoring a chapter on orphan drug regulatory pathways in "Fundamentals of International Regulatory Affairs (4th Edition)" and holds a U.S. patent for a pioneering technology in nucleic acid analysis. As a keynote speaker, she has presented on topics such as gene and Cell Therapy, Rare Diseases, and Immuno-Oncology at prestigious events, including RAPS Regulatory Convergence and the Orphan Drug Global Congress. With advanced credentials, including a Stanford Ignite Certificate (Business Management), an MS in Biotechnology from Georgetown University, and a Regulatory Affairs certification from RAPS, Mridula continues to lead innovation and advocacy in global regulatory compliance.