Keerti Tadimeti
Regulatory Affairs Scientist @Organon
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WORK HISTORY
Regulatory Affairs Scientist @Organon
Product Sub-Lead: •Assist with managing regulatory issues and maintaining submission information within CMC systems •Tracking global regulatory timelines and commitments for various products •Contribute to Health Agency query responses and review quality CMC submissions Regulatory Materials Compliance: •Work closely with Global Trade Compliance and import planners by reviewing regulatory information and relevant documentation needed for importation of drug products •Conduct direct verbal and written communications with FDA Import Operations to facilitate clearance of imported drugs •Advise on regulatory import/export strategies for commercial, investigational, and R&D materials •Oversight of Import for Export (IFE) program and Export Certification Submissions for investigational drugs and biologics •Submit and maintain applicable drug listings and establishment registrations with FDA •Analyze and submit drug manufacturing data related to the CARES Act (FD & C Act, Section 510)
EDUCATION
University of California, Davis
Bachelor’s Degree, Global Disease Biology
University of Pennsylvania School of Medicine
Masters of Regulatory Affairs, Regulatory Affairs
Northwestern University Pritzker School of Law
Master of Science - MS, Law
ABOUT KEERTI TADIMETI
Dedicated professional with a focus in regulatory science and healthcare with a passion…
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