EDUCATION
Long Island University, Brooklyn, NY April 2010
Master of Science in Regulatory Affairs (GPA: 3.54)
Saraswathi Vidya Bhawan College of Pharmacy, India August 2008
Bachelor of Pharmacy Equivalent to BS in pharmaceutical Science (USA) (GPA: 3.50)
NCRD’s College of Pharmacy, India
Diploma in Pharmacy Equivalent to Associates in Pharmaceutical Science (USA) August 2005
(GPA: 4.00)
ACHIEVEMENTS
RECEIVED A GOLD MEDAL AND CERTIFICATE OF MERIT FOR ACADEMIC EXCELLENCE IN DIPLOMA IN PHARMACY.
PROFESSIONAL EXPERIENCE
September 2009 – Present: Regulatory Affairs Intern at DRA Solutions. USA
• Presented a webinar on Regulatory Certification Program (RCP) for DRA Solutions. This presentation is used as a template by the Marketing department of the company for RCP presentations worldwide.
• Review and compiling of documents for preparation of Investigational New Drug Application (IND), Abbreviated New Drug Application (ANDA) and Biologics License Application (BLA).
• Review and compiling of documents required for registration of neutraceuticals with ANVISA, Brazil.
• Preparation and review of documents required for the registration of drugs in India (CDSCO), China (SFDA), Mexico, and Europe (EMEA).
• Preparation and submission of 510(k)
May 2006 – June 2006: Jasmika Health Care Private Ltd.
• Sampling and performing Screening Tests and Identification Tests on raw materials.
• Sampling and performing Quality control Tests on Finished drug product.
• Documentation of the test results and getting it approved by the Quality Control Head.
PROJECTS
Prepared an Investigational New Drug Application (IND) for a fictitious drug NOFIT® (Phenymazapine) in eCTD format:
- Played the role of a Project Manager in a team of four people.
- The project was segmented within the group and I prepared Module 3 (CMC) and Module 5 (Clinical Study) of the IND.
- Review and compiling of the entire IND.
- Brief presentation on the above IND to give an overview of the drug product.
SEMINARS
• Investigational New drug application
• Abbreviated new drug application
• High Performance Liquid Chromatography (HPLC)
• Quality of life
• Pharmacogenomics