Sarah Shi
Director Global Regulatory Affairs CMC at BeiGene | Rockville, Maryland, United States
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Sarah Shi is a highly accomplished Director of Global Regulatory Affairs CMC at BeiGene, where she leverages over 20 years of extensive experience in drug development to drive innovative solutions in the biopharmaceutical landscape. Her role is pivotal in shaping the regulatory strategies for complex biologics, antibody-drug conjugates (ADCs), and emerging modalities in cancer therapy. Sarah leads a dynamic team of regulatory affairs professionals, fostering a collaborative environment that emphasizes scientific rigor and regulatory compliance.
Her deep expertise in CMC (Chemistry, Manufacturing, and Controls) regulatory affairs is complemented by a robust scientific background in molecular biology, biochemistry, and immunology. This unique blend of skills enables her to navigate the intricate regulatory pathways associated with biologics and cell and gene therapies, ensuring that BeiGene's products meet the stringent requirements of global markets. Sarah's commitment to staying abreast of current regulatory intelligence allows her to anticipate challenges and identify opportunities for innovation, ultimately enhancing the efficiency of dossier submissions.
Key projects under her leadership include the development and submission of regulatory filings for cutting-edge therapies aimed at treating various forms of cancer, where her insights into assay development and drug discovery have proven invaluable. Sarah's ability to communicate complex CMC concepts clearly and effectively has established her as a trusted advisor within the organization and the broader pharmaceutical industry. Her passion for advancing cancer therapies through regulatory excellence continues to drive BeiGene's mission of transforming patient outcomes worldwide.
Director Global Regulatory Affairs CMC at BeiGene in July 2022 to Present
Associate Director of Global Regulatory Affairs, CMC at AstraZeneca in September 2019 to June 2022
Senior Manager of Regulatory Affairs, Cell & Gene Therapy at Kolon TissueGene, Inc. in February 2019 to September 2019
Scientist- CMC Regulatory Writing at Prometic Bioproduction Inc. in June 2016 to February 2019
Associate scientist II , Translational Medcine Oncology at AstraZeneca in July 2010 to May 2016
Scientist, high throighput screening and assay support at AstraZeneca in May 2007 to July 2010
Biochemist at Merck in March 2003 to May 2007
Biochemist at GSK in May 2002 to March 2003
Research associate at Pfizer in January 2000 to January 2002
Research associate at Cleveland Clinic in January 1999 to January 2000
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Assay Development
Molecular Biology
High Throughput Screening
Virology
Biochemistry
Sop
Translational Medicine
Immunology
Life Sciences
Drug Discovery
Microbiology
Oncology
Pharmaceutical Industry
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Discover more about BeiGeneWhat is Sarah Shi email address?
Email Sarah Shi at [email protected]. This email is the most updated Sarah Shi email found in 2026.
How to contact Sarah Shi?
To contact Sarah Shi send an email to [email protected].
What company does Sarah Shi work for?
Sarah Shi works for BeiGene
What is Sarah Shi's role at BeiGene?
Sarah Shi is Director Global Regulatory Affairs CMC
What is Sarah Shi's Phone Number?
Sarah Shi's phone (301) ***-*395
What industry does Sarah Shi work in?
Sarah Shi works in the Biotechnology Research industry.
Sarah Shi Email Addresses
Sarah Shi Phone Numbers
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