Audrey Egan is a regulatory affairs professional with 15 years of experience in planning, managing, and filing regulatory submissions to agencies globally for brand, generic and over-the-counter drugs.

Associate Director, Regulatory Affairs @ From January 2013 to Present (3 years) Associate Manager, Global Regulatory Operations @ From August 2004 to December 2012 (8 years 5 months) Sr. Regulatory Coodinator, Worldwide Regulatory Coordination @ From January 2001 to August 2004 (3 years 8 months) Regulatory Affairs Associate @ From 1998 to 2001 (3 years) Regulatory Assistant @ From 1997 to 1998 (1 year)

BSc Honors, Biology @ University of Toronto From 1992 to 1997 Audrey Egan is skilled in: Pharmaceutical Industry, Regulatory Submissions, Regulatory Affairs, FDA, Clinical Trials, Clinical Development, Sop, GMP, GCP, Oncology, Regulatory Requirements, IND, CRO, Generic Programming, eCTD, 21 CFR Part 11, Biopharmaceuticals, CTMS, SOP