Tejash Shah
Director, Biopharm Cmc Regulatory Affairs @GSK
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WORK HISTORY
Director, Biopharm Cmc Regulatory Affairs @GSK
Responsible for the CMC regulatory activities of multiple projects and dosage forms. • Represent Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing regulatory advice and guidance to Preclinical Development (PCD), Global Manufacturing and Supply (GMS), Clinical Supplies, Commercial, Quality Assurance, 3rd Party Contract Management and Office of the Chief Medical Officer (OCMO) to produce appropriate CMC components for global regulatory dossiers with appropriate guidance from supervisor, as necessary. • Understand and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications. • With management oversight, as necessary, ensure all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply. • Ensure all appropriate CMC regulatory aspects to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines • Manage multiple projects and teams simultaneously and provides data assessment and conclusions within and across departments. • Independently identify risks associated with submission data and information packages.
EDUCATION
South Gujarat University
Bachelor's degree, Pharmacy
University of Hertfordshire
Master's Degree, Pharmacology
SKILLS
ABOUT TEJASH SHAH
Tejash Shah is a Director, Biopharm CMC Regulatory currently working on Biopharm…
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