Asmita Khorjuvenkar
Regulatory Affairs Assosciate-ii at Teva Pharmaceuticals
Based in Bengaluru, India
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Seniority
Staff
Department
Science
Location
Bengaluru
Industry
Pharmaceutical Manufacturing
Company size
30K
Contact information
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a•••••••@tevapharm.com
Phone
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Background
About Asmita Khorjuvenkar
A tenacious result driven regulatory affairs professional with more than 10 years of experience in pharmaceutical industry. Throughout the experience, I developed technical competence, regulatory policy knowledge, and chemistry, manufacturing, and controls (CMC) expertise.I am experienced in Solid Dose manufacturing environment with USFDA and EU approved sites. and has knowledge of regulatory guidelines of FDA, EMA and International markets. Knowledge of the cGMP/GDP/GLP, Quality agreement, Audit management, ICH guidelines, Quality assurance, Change management, Dossier compilation, regulatory compliance, inspection readiness, product market complaints, DL response, CTD and eCTD, SOP, Data integrity.
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