Ansha Khurana

Regulatory Affairs Manager @Cliniexperts Research Services

West Delhi, DL, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2025 — Present

Regulatory Affairs Manager @Cliniexperts Research Services

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Delhi, IN

Managing the Regulatory for local and global clinical trials

EDUCATION

2006 — 2011

Jamia Millia Islamia

Post Graduate, Biotechnology & Bioinformatics

2004 — 2006

Govt. Girls Sr. Sec. School

Higher Secondary, Medical

N/A

Govt. Co-Ed. Sr. Sec. School

Secondary, General

SKILLS

Tissue CultureRegulatory SubmissionsDna ExtractionBiotechnologyAgarose Gel ElectrophoresisRegulatory AffairsPurificationOnline Registartion of BiologicalsGmpLife SciencesMicrobiologySds-PageCoppDnaElisaPcrMolecular BiologyGeneticsChromatographyCell BiologyCell CultureBioinformaticsMedical DevicesGel ElectrophoresisDrug Regulatory AffairsWestern BlottingLaboratoryCancer

ABOUT ANSHA KHURANA

Assistant Manager -Regulatory Affairs at Biocon Biologics. 9+ years experience in managing drug and Biosimilars Regulatory as per requirements of CDSCO and ICH-CTD guidelines. Expertise: Marketing Authorization, Change Control, Variations (Post Approval Changes) and Investigational New Drug (IND/NDA) dossier preparation and filling as per ICH-CTD guidelines. Developing regulatory strategies for Drug and Biosimilars clinical trials to post-marketing activities. Attending Subject Expert committee Meetings and discussions with or on behalf of the clients.

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Ansha Khurana — Regulatory Affairs Manager at Cliniexperts Research Services in West Delhi, DL, IN | Unifers