Ansha Khurana
Regulatory Affairs Manager @Cliniexperts Research Services
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WORK HISTORY
Regulatory Affairs Manager @Cliniexperts Research Services
Delhi, IN
Managing the Regulatory for local and global clinical trials
EDUCATION
Jamia Millia Islamia
Post Graduate, Biotechnology & Bioinformatics
Govt. Girls Sr. Sec. School
Higher Secondary, Medical
Govt. Co-Ed. Sr. Sec. School
Secondary, General
SKILLS
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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