Jeanine Kuczik began providing independent regulatory consulting services as JEK Pharmaceutical Consulting in 1996. She has been responsible for regulatory strategy and submission oversight of IND/NDA/ANDA/505b2/510K and MAA regulatory filings and routinely interfaces with FDA on behalf of sponsors, often serving as a virtual regulatory affairs department on their behalf. Recent projects have included submissions in therapeutic areas including neurology, pain, psychiatry, and cardiovascular products. She has additionally managed sponsor meetings with European and Canadian regulatory agencies to agree on appropriate regulatory filing strategy.

Jeanine received her BS in Pharmacy from the University of Connecticut and began her professional career in Pharmaceutical Development at Boehringer Ingelheim. She then relocated to NC to work for Glaxo Inc. where she held increasing roles of responsibility ranging from regulatory affairs submissions and strategy for Glaxo’s anti-infective and neurology drug products and was asked to take on the lead regulatory affairs role in the newly formed Glaxo Dermatology Business Division. Her experience also included leadership in the Glaxo International Project Management Division.