Amrita Ghosh

***** ***** *** #***

Cupertino ****4

a ac0e5n@r.postjobfree.com

https://www.linkedin.com/in/amrita-ghosh-71490024

510-***-****

Key experience:

● Prepared pre–approval regulatory submissions including original INDs and NDAs, IND amendments and post–approval CMC supplements (CBE-30 and CBE-0) using Word, Adobe, ISI Toolbox

● Managed the production of early stage R&D batches. Successfully done technology transfer from research center to manufacturing unit, and audited manufacturing batches.

● Worked on US FDA projects for major pharmaceutical companies, such as Boehringer Ingelheim, Watson Pharmaceutical, Perrigo, Teva pharmaceuticals.

● Reviewed Phase 1-3 Clinical Study Reports (CSR), trial master files and investigator site files. Education:

Regulatory Affairs and Medical Device Certification ongoing

UC Santa Cruz, Silicon Valley Campus

Bachelor of Pharmaceutical Sciences

June 2004

Mumbai University, Mumbai, India

Certificate in Quantitative Methods in Clinical & Public Health Research Jan 2013

Harvard School of Public Health through EDX

Certificate in Data Management for Clinical Research Nov 2013 Vanderbilt University through Coursera

Experience:

Educational Testing Service (ETS), Cupertino, CA

Constructed Response Scorer August 2016 -

Present

Starting a family and taking academic courses. Oct 2010 – August 2016 Cipla Ltd., Mumbai, India Aug 2006 – Sep 2010

Regulatory Affairs Officer (Team Lead)

● Supervised groups of 4–6, including project management, training and performance evaluation.

● Prepared, wrote and reviewed regulatory IND, NDA and ANDA submission dossiers for the U.S. market.

● Authored two Antihypertensive NDAs from 2006–08 and 2007–09. Authored and submitted 5 ANDA submissions.

● Participated in clinical trial initiatives including reviewing and submitting to the FDA the safety sections for clinical drug submissions (Clinical Safety Reports, NDAs, INDs).

● Took ownership of the success of FDA submissions through effective regulatory strategy, gap analysis, authoring of CTD and deficiencies.

Glenmark Pharmaceuticals Ltd., Mumbai, India Jul 2004 – Aug 2006 Technical Assistant in Research and Development

Reported to General Manager, Drug Development for ANDA U.S. market.

● Assisted in Drug R&D. Prepared batch records, development reports and master formula reports.

● Successfully done technology transfer and contributed in the development of new drug products. Pfizer Inc., Mumbai, India (internship) Jun 2003 – Jul 2003 Trainee

● Assisted Pfizer Research Officers in research and development, production and quality control.

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