Louise Johnson
About Louise Johnson
Louise Johnson is the Executive Director of Regulatory Affairs at Nektar Therapeutics, with extensive experience in regulatory roles across various companies. She holds a Bachelor of Arts in Psychology from UC Santa Barbara and a Master of Science in Applied Statistics from Villanova University.
Work at Nektar Therapeutics
Louise Johnson has served as the Executive Director of Regulatory Affairs at Nektar Therapeutics since 2011. In this role, she oversees regulatory strategies and compliance for the company's drug development programs. Her responsibilities include ensuring that all regulatory submissions meet the necessary standards and guidelines. Johnson's extensive experience in regulatory affairs contributes to Nektar's ability to navigate complex regulatory environments effectively.
Education and Expertise
Louise Johnson holds a Bachelor of Arts in Psychology from the University of California, Santa Barbara, where she studied from 1976 to 1978. She also earned a Master of Science in Applied Statistics from Villanova University, completing her studies from 1985 to 1992. Johnson possesses expertise in safety pharmacology and Good Laboratory Practice (GLP) compliance, which are essential in the regulatory landscape of pharmaceuticals.
Background in Regulatory Affairs
Johnson has a diverse background in regulatory affairs, having held various positions across multiple organizations. Prior to her current role, she worked at Cygnus Business Media as Manager of Regulatory Affairs from 1994 to 1995. She also served as Director of Regulatory Affairs at Elan from 1999 to 2002 and held senior positions at companies such as Neuraltus Pharmaceuticals, Renovis, and Pain Therapeutics, Inc. Her career spans over two decades in the regulatory field.
Achievements in Drug Submissions
Throughout her career, Louise Johnson has successfully negotiated the approval of two New Drug Submissions (NDSs) in Canada. She has also participated in an FDA Advisory Committee meeting for the Diastat NDA, showcasing her involvement in significant regulatory processes. Her contributions include providing regulatory support for European submissions and specializing in the regulatory aspects of Active Pharmaceutical Ingredient (API) and drug product manufacturing.