2024 PDA/FDA Joint Regulatory Conference

Janeen Skutnik-Wilkinson Moderna, Inc.

Janeen Skutnik-Wilkinson

Janeen Skutnik-Wilkinson Moderna, Inc. Director, Global Quality, Regulatory Surveillance & External Engagement

Ms. Skutnik is the Director of Regulatory Surveillance in Global Quality at Moderna. Her former positions include: Director, Global Regulatory CMC Regulatory Intelligence at Biogen, Association Director, Quality Intelligence at Biogen, Vice President at NSF DBA, Director /Team Leader of Quality & Regulatory Policy at Pfizer. In these roles she was responsible for working with trade associations and developing company positions on Quality and CMC issues, monitoring global regulations/guidelines/standards. She has over 28 years experience in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She served on PDA's RAQAB, and is the co-chair of PDA's Pharmacopoeial IG. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was on the EWG for Q3D. She was the Chair of PhRMA’s Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic – Q4B. She was the chair of the IPEC organisation twice, and was also president of the IPEC Federation. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.