Janeen SkutnikWilkinson

Regulatory Intelligence and Pharmacopoeial Affairs
Biogen

Ms. Skutnik-Wilkinson is currently with BIOGEN where she is responsible for Regulatory Intelligence and Pharmacopoeial Affairs. Previously she was the Vice President of NSF Health Sciences Pharma-Biotech. Before that, she was the Director of Quality Strategy at Pfizer, and was responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues on a global scale. Janeen has over 22 years of experience and expertise in compendial activities, quality and regulatory policy. She also has held a variety of positions spanning from responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik-Wilkinson earned a Bachelors of Science from the University of Connecticut in 1994. Ms. Skutnik-Wilkinson is Past-Chair of the International Pharmaceutical Excipients Federation (IPEC Fed). She is also past-Chair of IPEC-Americas and served as Chair of IPEC Compendial Review/Harmonization Workgroup (1999 – 2007). She sits on the ICH Assembly (formerly known as the steering committee) as a representative for IPEC Federation, and is also actively involved in PDA, PhRMA and BPOG.