Masters of Science in Regulatory Affairs of Drugs, Biologics and Medical Devices
Skills
Solid working knowledge of FDA regulations • ISO standards • ICH GCP guidelines • GMP in the drug industry. Proficient wit... • Lotus Notes • Acrobat • Clinical eData Capture tools (Oracle Inf... • MedDRA. Profound knowledge of Drug and D... • team player with excellent oral and writ...
License Records
Siddhartha Chowdhury
Address:
Newton, MA 02460
License #:
27215 - Active
Issued Date:
Jan 19, 2010
Expiration Date:
Jun 30, 2017
Type:
Certified Public Accountant
Resumes
Experienced Professional And Graduate Student (Masters, Regulatory Affairs) Actively Looking For Internships
Tata Consultancy Services / GlaxoSmithKline Mumbai, Maharashtra Dec 2009 to Jun 2010 Regulatory Clinical Affairs AssociateMerck Serono India Goa May 2008 to Jul 2008 Regulatory Affairs Quality Intern
Education:
Northeastern University Boston, MA 2010 to 2012 Masters of Science in Regulatory Affairs of Drugs, Biologics and Medical DevicesMumbai University Mumbai, Maharashtra 2005 to 2009 Bachelor of Pharmacy in Pharmaceutical Sciences
Skills:
Solid working knowledge of FDA regulations, ISO standards, ICH GCP guidelines, GMP in the drug industry. Proficient with MS Office, Lotus Notes, Acrobat, Clinical eData Capture tools (Oracle Inform), MedDRA. Profound knowledge of Drug and Device Development process and Clinical Research terminology. Ability to maintain good working relations, team player with excellent oral and written communication skills.