Lingling Rogers
Executive Director, Regulatory Affairs @Sumitomo Pharma America, Inc.
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WORK HISTORY
Executive Director, Regulatory Affairs @Sumitomo Pharma America, Inc.
Irvine, CA, US
EDUCATION
Purdue University
PhD, Medicinal Chemistry & Pharmacognosy
University of San Francisco
MS, Organic Chemistry
SKILLS
ABOUT LINGLING ROGERS
Over 20 years of experience in pharmaceutical industry and 15 years in regulatory affairs CMCStrong technical knowledge of drug development and related global CMC regulations/guidelines for small molecules, biologics, and drug/device combination productsExtensive experience in leading the preparation and submission of global regulatory dossiers for development projects and commercial productsExperience in leading CMC related interaction and strategic negotiation with regulatory agencies through written communications, teleconferences, and face to face meetingsExperience in leading the site pre-approval inspection (PAI) activities as well as on-site FDA interactions for the approval of NDAExperience serving on cross-functional due diligence teams performing critical reviews of third party regulatory dossiers for potential in-license opportunitiesHighly motivated and data-driven, with strong written and verbal communication and presentation skills
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