Vice President, Regulatory Affairs
Marcy Macdonald is Vice President of Regulatory Affairs at Tolmar, Inc. Marcy has been in pharmaceutical regulatory affairs for over 25 years, providing global regulatory leadership and expertise to her teams, the business and board of directors. Her responsibilities have included guidance in support of ANDA/NDA pre-and post-approval activities, advertising and promotion, labeling, regulatory operations and compliance as well as providing functional expertise to the business in relation to acquisitions and integration initiatives.
Prior to joining Tolmar, Marcy was owner/principal with MJM Regulatory Consulting, LLC and Vice President Regulatory Affairs at Amneal. She has also held several senior director level positions with Sandoz and Hospira, leading teams in ANDA and biosimilar regulatory activity, and at Apotex Corp, where she had responsibility for the development of their U.S. regulatory operations. Marcy is also active externally having served as chair and/or member of various Industry/Agency committees and served on the AAM Board of Directors.