1. Nirav. A. Gandhi
B-16, Lijjat Godavari CHS, M.G.Road, Kandivali (West), Mumbai 400067. 9619755906.
n.a.gandhi@hotmail.com
Objective A challenge seeking and results-oriented individual, willing to
make carrier in Pharmaceutical/Biotech Industry.
Education Aug 2006 – May 2009 Campbell University NC, USA
BS Pharmaceutical Science.
Jan 2001 – Aug 2003 M.E.T Institute of Pharmacy Mumbai, India.
Diploma in Pharmacy.
Professional Industrial Pharmacy: Manufacturing Tablets, Capsules, Emulsion,
Coursework Suspensions, Powder.
Biotech: Gel Electrophoresis, PCR, Affinity Chromatography, ELISA,
DNA Purification.
Analytical Instrumentation: HPLC, GC, LCMS, UV-Vis, SAS JMP.
Product & Process Validation: IQ/ OQ on HPLC. cGMP &
Documentation
Experience Jan 2014 – to Present. BDH Industries Ltd. Mumbai.
Trainee Regulatory Affairs
• Preparation and submission of registration dossier in Country Specific and ACTD
format for countries in South Africa and Srilanka.
• Co-ordinating with Plant, R&D and QA/QC department for technical documents and
to review the documents for accuracy and recommend corrections as per ICH or
country specific guidelines.
• Preparing accurate and timely responses to queries received for regulatory agencies
• Checking & approval of artworks as per countries requirement.
• Arranging samples, working standard, artwork as per country requirement and
submit them to regulatory authority within specified time frame
• Maintaining the E-copy and checklist as back up for submission
• Communicating and follow up with agent for progress of registration submission
• Maintaining record for the Dossier and tender sample submission
• Maintaining & updating country wise registration status and arranging for renewal
• Filling Tender with samples and technical documents within specified time frame
• Application and Renewal of COPP’s, Additional Product
Manufacturing Licence, WHO-GMP Certificate, GMP Certificate, Narcotics Drug
Manufacturing License and Free Sale Certificate.
February 2012 – Dec 2014 New India Drug Co. Mumbai.
Manager.
Retail Store. (Pharmacy)
March 2009 – May 2009 Emory University Hospital Atlanta, USA
Research Assistant. (Internship)
•Conducting Western blots on mouse skeletal and heart muscles.
•Conducting Gel Electrophoresis, PCR on transgenic mouse tails.

2. •Worked with supervisor to plan and schedule own activities necessary to meet
Timelines.
• Supported testing of new technologies and targets for research within
functional area.
• Generated data to support publications, posters, presentations, and
internal document.
• Summarized results, contribute to the generation of technical reports, and
Completed experimental paperwork/ lab notebook documentation.
• Worked cooperatively with process development, quality, manufacturing
regulatory, Clinical and marketing to ensure project success.
Aug 2006 – Dec 2008 Campbell University NC, USA
Research Assistant.
• Franz cell Diffusion studies on Human Insulin through semi
synthetic membrane.
• Performed bacterial cell lysis of E. coli using Bugbuster reagent,
utilized 96 well-plate. Measured absorbance to determine the
concentration of protein and studied stability. Extracted protein
from E. coli cells.
Sep 2004 – Aug 2005 New India Drug Co. Mumbai, India.
Licenced Pharmacist.
• Handled Account transactions, acquired and submitted
Prescription Rx orders, as well provided customer service to
clients of the establishment.
Oct 2003-Aug 2004 Vival Laboratories. Mumbai, India.
Manufacturing Chemist.
• Weighed Chemicals used for the manufacturing Anti Dandruff
Shampoo, Prepared S.O.P’s for the manufacturing process,
Created cGMPs layout for the manufacturing plant. Recorded pH
of water, liquid chemicals, solvents and chemicals used for
general purposes and finished products.
Membership ISPE, AAPS, SAATH (South Asian Awareness Through Humanities)
Campbell University Cricket Club sport (CUCC)
“RELAY FOR LIFE” (Breast Cancer Research)
Languages English, Hindi, Gujrati, Marathi.