Amit Patel is seeking a career in international regulatory affairs. He has a Master's degree in Pharmacy from Jaipur National University and over 7 years of experience in regulatory affairs and quality assurance. Currently he works at Nirlife Healthcare preparing regulatory dossiers for several African and Latin American countries using CTD format. Previously he worked at Mediwin Pharmaceutical. He has strong computer skills and experience with regulatory software.

1. RESUME
Amit R. Patel M. Pharm (Quality Assurance)
OPP. Gujarat stadium, near Sangath 1, Mobile: +917041300344
Bungalows, Motera road, +919033106413
Sabarmati, E mail: amitpatel4013@hotmail.com
Ahmedabad 380005 amitpatel4013@gmail.com
CAREER OBJECTIVE:
To obtain a challenging career in the International Regulatory Affairs and be a part of
progressive organization which gives me opportunity to utilize the best of my ability in the
scope of organization with sheer determination, dedication and hard work.
EDUCATIONAL QUALIFICATION:
Name of examination Board Class Passing year
Master of Pharmacy
Jaipur National University,
Rajashthan
First 2009-11
Bachlour of Pharmacy
Hemchandrachary North Gujarat
University, Gujarat
First 2005-08
Diploma of Pharmacy Gujarat University Second 2004-05
H.S.C Gujarat Board Pass 2003
S.S.C Gujarat Board First 2001
M. Pharm Dissertation Title:
Development and Validation for Simultaneous Estimation of Telmisartan and Indapamide
Pure and Marketed Formulation.
PROFESSIONAL EXPERIENCE:
CURRENT JOB –
Working as an officer in International Regulatory Affairs Department at Nirlife
Healthcare (A Division of Nirma Limited) since 20.06.2012.

2. JOB PROFILE –
 Prepare CTD Dossier by Knowledge NET software (Sarjan System Pvt. Limited)
 Prepare Dossier of South Africa Country (MCC)
 Coordination work between the Regulatory Affair department and International
marketing team. (Prepare Presentation, maintain Excel sheet of registration and
pending Dossier)
 Prepared Dossiers for semi regulatory markets for SVP, LVP, Dry Powder, Medical device
and Tablet.
 Experience in regulatory affairs market Africa, Latin America & having knowledge of
CTD/ACTD guidelines formats/ modules and ICH Guidelines.
 Compile and prepare for quick responses to regulatory authorities queries and medical
quires via Knowledge NET software. (Sarjan System Pvt. Limited)
 Checking of dossiers / Artwork of products / Technical documents.
 Preparation of legal documents like FSC, COPP.
 Preparation of Tender document.
 Maintain regulatory files in a format consistent with requirements.
DOSSIER PREPARATION FOR AFRICA (AS PER CTD FORMAT- KENYA, UGANDA,
ZIMBABWE, GHANA, TANZANIA, MALI)
As per specfic guideline require (MAURITIUS, MOZAMBIQUE, R.D. CONGO,
BOTSWANA, MALAWI)
 SOTH AFRICA: MCC
 EAST AFRICA: KENYA, UGANDA, TANZANIA, ETHIOPIA.
 SADC: ANGOLA, RD CONGO, MALAWI, MOZAMBIQUE, ZAMBIA, MAURITIUS,
ZIMBABWE, BOTSWANA.
 WEST & FRENCH AFRICA: GHANA AND NIGERIA
 LATIN AMERICA: MAXICO, GUANTEMALA AND PERU
 Done a Method Development, Validation and Prepare a Validation protocol.
 Done an Assay, Dissolution, and RS in Zydus-Cadila PTC Department.
 Shimadzu UV in Zydus-Cadila PTC Department & Mediwin Pharmaceutical
 Electrolab, Lab India Dissolution in Zydus-Cadila PTC Department & Mediwin
Pharmaceutical.
PREVIOUS JOB –
Worked as an officer at Mediwin Pharmaceutical from February 2011- June 2012.

3. COMPUTER LITERACY
Proficient in M. S. Office, Word, Internet, Excel and SAP, CTD Software
CONVENTIONS ATTENDED AND POSTER PRESENTATION:
 Research paper “Method Development and Validation of Simultaneous Estimation
Telmisartan and Indapamide by Reverse Phase-High Performance Liquid
Chromatography in Pharmaceutical Dosage Forms” in Asian Journal of Biochemical and
Pharmaceutical Research in 2011 march.
 Research paper “Method Development and Validation and stability study of Simultaneous
Estimation Telmisartan and Indapamide by Reverse Phase-High Performance Liquid
Chromatography in Pharmaceutical Dosage Forms” in International journals of
pharmaceutical and biological research in 2011 march.
 Poster Presented at AICTE sponsored National Seminar at Chhattisgarh in March 2010.
 Poster Presented at Technorazz,2009 held at Jaipur National University, Jaipur in
December 2010
 Paper acceptance in IPCA held Seminar in Shikkim, 2010, Analytical and Regulatory
topics.
PERSONAL DETAILS:
Name : Patel Amit Rameshbhai
DOB : 24th
August 1986
Father Name : Patel Rameshbhai R
Gender : Male
Religion : Hindu
Nationality : Indian
Marital Status : Married
Hobbies : Cricket, Music
Languages Known : English, Hindi, and Gujarati
DECLARATION:
I declare that above mentioned details are completely true to the best of my knowledge.
Place: AHMEDABAD
Date: Yours faithfully,
AMIT PATEL