Puja Chhabria
Senior Manager, Global Regulatory Operations @Sarepta Therapeutics
Signup · Get unlimited contacts
WORK HISTORY
Senior Manager, Global Regulatory Operations @Sarepta Therapeutics
CA, US
EDUCATION
University of Mumbai
Bachelor in Pharmaceutical Sciences, Pharmaceutics
Bombay College of Pharmacy
Post Graduate Diploma in Clinical Research, Clinical Research
Northeastern University
Master's degree, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
SKILLS
ABOUT PUJA CHHABRIA
Experienced, quick learner, highly competent Regulatory Affairs Associate with specialization in regulatory CMC (developed CTA checklist, CMC guidance library)/ Strategy (CI)/ Operations (QC of IND), acquired experience at Alnylam Pharmaceuticals, Cambridge, MA Experienced in Regulatory information management and filing specializing in creating, updating SOPs for record management MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Boston Trained in US FDA Drug Approval, Regulation & Compliance from CfPA. Excellent Knowledge of Regulations 21 CFR, 210-211(cGMP), GxP, ICH Proficient in MS office (Word, Excel & PowerPoint) with high attention to detail and ability to work independently or as part of team. Six months of experience in Packaging Development Department for Cipla Ltd. as a Trainee. Completed Post Graduate Diploma in Clinical Research (PGDCR) from Academy of Clinical Research Graduated with First Class in Bachelors of Pharmaceutical Sciences degree from Mumbai University, India. Authorized to work in the United States
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.