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