Jan Eilert
Senior Scientist, Cmc Regulatory Sciences @Cardinal Health
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WORK HISTORY
Senior Scientist, Cmc Regulatory Sciences @Cardinal Health
Serve as senior consultant to big pharmaceutical companies with the following accomplishments:• Authored submissions to meet FDA, ANVISA, NMPA, Latin America, ASEAN, and EU regulations. • Developed and implemented CMC strategies for post-approval changes and health authority queries to global marketing applications. • Managed complex projects and shifted priorities across multiple portfolios to meet milestones with a focus on quality and timely submissions.• Managed cross functional collaboration with stakeholders to support multiple projects.
EDUCATION
Peking University
Bachelor of Science - BS, Chemistry
Illinois Institute of Technology
Doctor of Philosophy - PhD, Analytical Chemistry
Kansas State University
Master of Science - MS, Analytical Chemistry
ABOUT JAN EILERT
Accomplished senior level Chemistry, Manufacturing, and Controls (CMC) professional with strong technical expertise in analytical method development and validation, formulation development, and all phases of product development from discovery through commercialization. My unique combination of technical and regulatory expertise enables me to provide strategic guidance in tackling complex and diverse projects from pre-IND to post-approval stages. I have successfully led teams developing NDA drug products, authored submissions, addressed regulatory agency inquiries and participated in FDA inspections and meetings.I have solid understanding of global standards and regulations and have prepared submission dossiers to meet FDA, ANVISA, NMPA, Latin America, ASEAN, and EU regulations.Innovate, analyze and solve problems with minimal supervision and attention to detail.
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