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...
West Bengal University of Technology, Kolkata 2007 - 2013
Master of Business Administration, Masters, Business Administration
Pailan College of Management & Technology 2011 - 2013
Master of Business Administration, Masters, Marketing, Management
St.thomas High School 1992 - 2003
Skills:
Market Research Microsoft Office Powerpoint Marketing Html Microsoft Excel Microsoft Word English Customer Service Public Relations Team Management Social Media Social Media Marketing Windows Research C Business Development Marketing Strategy
United Nations
Erp Systems Administrator
Marsh May 2009 - Oct 2009
Peoplesoft Upgrade Consultant
Expertus Oct 2008 - Apr 2009
Peoplesoft Consultant
Birlasoft Jan 2006 - Jan 2009
Project Manager
Bag Networks Sdn Bhd Feb 2002 - 2005
Peoplesoft Technical Consultant
Education:
University of Burdwan 1992 - 1994
Bachelors, Bachelor of Science
Skills:
Oracle Requirements Analysis Databases Erp Business Analysis Data Migration Peoplesoft Unix Sql Testing Security Analysis Integration Production Support Crm Microsoft Sql Server Business Intelligence Performance Tuning Disaster Recovery Crystal Reports Pl/Sql
Interests:
Children Education Environment Human Rights Health
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.