Marcy Macdonald has a significant amount of experience in the field of regulatory affairs, with expertise in ANDA/biosimilar/505(b)(2) submission strategy, review and guidance, establishing best practices for regulatory affairs departments, and promotional review and labeling systems. Marcy has held positions of increasing responsibility, including Vice President of Regulatory Affairs at Tolmar, MJM Regulatory Consulting, Amneal Pharmaceuticals, and Impax Laboratories. Marcy has also served as Director and Senior Director of Regulatory Affairs at Sandoz, and as Associate Director and Director of Regulatory Affairs at Hospira. Marcy started their career as a Manager-Director of Regulatory Affairs at Apotex Corp. Marcy has also led regulatory affairs activities for due diligence projects resulting in product licensing, mergers, and acquisitions.
Marcy Macdonald obtained a Bachelor of Science (BS) degree in Microbiology from the University of Illinois Urbana-Champaign. Marcy later pursued a Master of Business Administration (MBA) degree in Finance/Marketing from the same institution. No specific start or end dates were provided for either degree.
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