1. CURRICULAM VITTAE
Name: PRUSHIN MANANBHAI THAKORE
Qualification: M.Pharma (Pharmacology)
Experience: Total 2.7 Years
Contact No: +91-7567095001
Email: thakoreprushin888@gmail.com
OBJECTIVE
I want to work in an environment where organizational growth is achieved overcoming
challenges, and where I can also grow while applying my knowledge, skills and experience.
Looking forward to rise the cadre in the organization to senior position, where I can help
the organization through my decisions taking responsibilities.
AREA OF INTEREST
Regulatory Affairs Department
WORK EXPERIENCE
From January, 20th
, 2013 to till Date
Working at CLARIS INJECTABLES LIMITED (Formally known as Claris Lifesciences
Limited) as Jr. Executive in Regulatory Affairs Department.
JOB RESPONSIBILITIES
Responsible for the preparation, maintenance and timely compilation of the documents
pertaining to regulatory requirements, recording complying high quality CTD format.
These documentation fully comply country specific guidelines and submissions for the
specific countries. Reviewing all relevant regulatory documentation - as prepared, and
ensuring them to be in line with the regulatory standards/requirements in the Far East
countries that includes Taiwan, Hong Kong and South Korea and Middle East and North
African countries and including GCC countries (Saudi Arabia, Kuwait, Oman, Qatar,
Bahrain and UAE ) and Jordan, Iran, Algeria, Syria, Lebanon, Morocco.
Responsible for handling communication with company partners in above listed
countries and responding / providing feedback on their queries and requirements in
agreed timeline. Responsible for coordinating and following up with the submissions
made.
Reviewing technical documentations (e.g. specifications, stability protocols and reports,
Batch Manufacturing Records, Process validation protocol and report, CoA etc.).
2. Preparation and Checking the Product Designs, Labeling and Artworks. Ensure their
compliance with respective and appropriate regulatory guidelines.
Arrange/organize to attest / legalize documents from embassies of various countries
for Registration and maintain records of the expenses involved.
Prepare and maintain the database (and its status) for dispatched dossiers, their
submissions and status on their country wise registrations.
Preparing application for Product Permission, Certificates of Pharmaceutical products
(COPP.)
Familiar with SAP system.
EDUCATIONAL QUALIFICATION
Examination Board/ University Year % Class
M.Pharm
Rajiv Gandhi
University of Health
Sciences, Karnataka
2012 76.5 First
B.Pharm
Rajiv Gandhi
University of Health
Sciences, Karnataka
2009 71 First
H.S.C
Gujarat Secondary and
Higher Secondary
Educational Board
2005 41 Pass
S.S.C
Gujarat Secondary and
Higher Secondary
Educational Board
2003 85 First
RESEARCH PROJECT (M.Pharm)
Completed six months dessertation project at GUJARAT CANCER RESEARCH INSTITUTE,
AHMEDABAD. The subject of the project undertaken was ESTABLISHING EPIDERMAL
GROWTH FACTOR RECEPTOR FOR ANTI-CANCER ACTIVITY IN TRIPLE NEGATIVE BREAST
CANCER CELL LINE
PERSONAL PROFILE
Date of Birth May 26, 1988
Nationality Indian
Gender Male
Marital Status Unmarried
3. Languages Known English, Hindi & Gujarati
Passport No M 1870192
Permanent Address
303, Pray Apartment,
36, Mahalaxmi Society,
B/h Unnati high School,
Paldi,
Ahmedabad 380 007
Gujarat
Hobbies
Reading, listning Music, Playing Cricket,
Football, Volleyball and Carrom
DECLARATION
I hereby confirm that all the above information as furnished is truly correct.
Place: Ahmedabad
Date :09/08/2015 Prushin Thakore