Erica Lee
Director @Alexion Pharmaceuticals, Inc.
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WORK HISTORY
Director @Alexion Pharmaceuticals, Inc.
Boston, MA, US
Responsible for Regulatory strategy of investigational and potentially life changing therapies.
EDUCATION
Clark University
Bachelor of Arts (B.A.), Chemistry and Biology
Babson Exec Program
Organizational Leadership
SKILLS
ABOUT ERICA LEE
Experienced Regulatory Affairs expert with a demonstrated history of working in the pharmaceuticals industry. Extensive experience in developing regulatory strategies for biologics, small molecules, and monoclonal antibody and in obtaining regulatory approvals with FDA, Health Canada, EMA, and international markets. Strong knowledge of current Good manufacturing Practice (cGMP), ICH guidelines, CMC writing for global regulatory submissions, Change Control, Validation, and High-Performance Liquid Chromatography (HPLC). RAC certified and strong business development professional with a Bachelor of Arts (B.A.) focused in Chemistry and Biology from Clark University.
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