Dr. Kenneth Surowitz is a seasoned Regulatory Affairs consultant with extensive experience providing expert consulting services to early-stage and established vaccine and biologics companies. He is well-versed in FDA communications and liaison and has a successful track record of interfacing with client project teams and executive management. Ken currently serves US and EU-based clients, and his consulting projects include infectious disease (viral) vaccines, therapeutic vaccines/advanced therapies, and biosimilars (monoclonal antibodies). He is also an Adjunct Professor in the QA/RA Graduate Program at Temple University, College of Pharmacy. He teaches courses on Vaccines-QA/RA Issues and Global CMC for Biologics.
Ken has held various senior positions in Regulatory Affairs in his professional career. He served as the Executive Vice President, Global Regulatory Affairs at Accord Healthcare (Intas) for North American markets. Ken led the Regulatory Affairs team for biosimilars, complex generics, and generic products. Before that, he oversaw global biosimilars development as Vice President of Regulatory Affairs (Biologics) at Dr. Reddy’s Laboratories. Ken also worked at GlaxoSmithKline as the Vice President of Global Regulatory Affairs – Biopharmaceuticals/Vaccines, where he organized and led the dedicated Biopharmaceuticals Global Regulatory Affairs (GRA) department. He also supported North American Vaccines Regulatory Affairs on an interim basis. Before joining GSK, he worked at Merck as the Senior Director of Regulatory Affairs, where he served as Therapeutic Area Lead for Merck BioVentures (biosimilars) and Adult Vaccine franchise. Ken began his career at Wyeth, where he spent 11 years and held various senior positions, including Director of Global Regulatory Affairs for Wyeth-Lederle Vaccines.
Ken has managed clinical regulatory, CMC, QA/QC, and analytical development throughout his career. He has led successful development programs for cancer vaccines, monoclonal antibodies, small-molecule opioid antagonists, and biosimilars. He is a respected figure in the Regulatory Affairs community. He has a proven track record of developing and implementing regulatory strategies that have led to the approval of new drugs and biologics.