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 corporate
Regulatory Affair coordinate with International Marketing 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:
Method Development and Validation of Simultaneous Estimation of Telmisartan and
Indapamide Pure and Marketed Formulation.
Project:
I worked as a project trainee at Analytical Development Department, Pharmaceutical
Technology Center, Zydus Cadila Healthcare Ltd., Ahmedabad from July 2010 to
February 2011.

2. Job Profile
 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.
 Electrolab, Lab India Dissolution in Zydus-Cadila PTC Department.
PROFESSIONAL EXPERIENCE:
CURRENT JOB –
Working as an officer in International Regulatory Affairs Department at Aculife
Healthcare- Nirlife Healthcare (A Division of Nirma Limited) since 20.06.2012
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)
 Prepare Data of Dossier Pending Issue from MOH site or Distribution site.
 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,

3. ZIMBABWE, BOTSWANA.
• WEST & FRENCH AFRICA: GHANA AND NIGERIA
• LATIN AMERICA: MAXICO, GUANTEMALA AND PERU
 PREVIOUS JOB –
Worked as Regulatory Officer in Regulatory Affair department at Mediwin
Pharmaceuticals Naroda G.I.D.C Ahmedabad from Feb 2011 to June 2012.
Job Profile
 Prepare Dossier Africa region Kenya, Ghana and Nigeria.
 Compile and prepare for quick responses to regulatory authorities queries.
 Assay of Raw material and Finished Product done by HPLC and Dissolution
Worked as Medical Representative at Ipca Laboratories Limited.,Mumbai (Intima
Divison) From 01/11/2008 to 10/08/2009 Ahmedabad Division.
Job Profile
 Planning marketing activities in conjunction with company’s growth plan and
working out strategies to execute the plan.
 Developing marketing reports to be presented at the meeting of top management.
 Developing systems and procedures to ensure that the leads generated are optimally
utilized.
 Managing the team of marketing executives.
 Planning marketing activities in conjunction with company’s growth plan and
working out strategies to execute the plan.
COMPUTER LITERACY
Proficient in M. S. Office, Word, Internet, Excel and SAP, CTD Software (knowledge Net)
Sarjan Sytem pvt., ltd.
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

4. 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