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Hirak Bhatia

Manager Global Regulatory Affairs CMC @ Shire

Hirak Bhatia Contact Details

Boston, Massachusetts
Manager Global Regulatory Affairs CMC @ Shire
Global Regulatory Affairs CMC @ Shire
Regulatory Affairs Officer @ Vital Laboratories Pvt Ltd
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs @ Massachusetts College of Pharmacy and Health Sciences

Prepare Regulatory submission (Investigator documentation, Annual Reports, Type A, B and C meetings, CMC documents) (21 CFR Part 201) Review Advertisement, labeling and Promotional material Coordinate labeling Changes Protocol review for manufacturing changes,adverse events, quality manual and SOP's Strong knowledge of GCP, ICH and FDA guidelines, Post Marketing Surveillance Development of regulatory strategy for future and current 

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