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Regulatory Affairs

Location:
United States
Posted:
May 25, 2010

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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



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