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Anupam patel 03y exp m.pharm (ra) & mba (internation bus)
1. A200
CONTACT
IMFORMATION
Address:
Plot No. 213 KH
No 133/1/7
Block A, Gali No.
7, Nangloi road,
Najafgarh, New
Delhi-110043
MOBILENO.
+918510984499/
+919555451890
E-mail
anupampatel07@
gmail.com
ANUPAM PATEL
MBA (Int. Business) & M. PHARMA (Regulatory Affairs)
PROFESSIONAL SUMMARY
A dynamic and result driven professional with approx 3 year of experience in
Pharmaceutical Industry where I have more than 2.6 years of rich experience of International
Drug Regulatory Affairs handling a range of Pharma, OTC & Narcotics & Psychotropics
Products for registration in ASEAN, African, Latam, Asian Nations.
Being also a MBA in International Business got chance to work in Product Management
Team (International), where I do Market Research & distributer search for Product's sales,
Brand Management, Design & Implement Marketing Strategies, Design of Promotional
Marketing inputs.
Strong communication, Interpersonal & Presentation skills, Analytical and strategic thinking
problem-solving skills, knowledge of marketing result-oriented attitudes, creativity,
prioritization and multitasking skills, leadership and people-management skills.
AREA OF INTEREST
International Business
Drug Regulatory Affairs
INDUSTRIAL EXPERIENCES (03 YEARS)
Presently working with VERVE HEALTH CARE LIMITED, NEW DELHI
(Corporate office of VERVE HUMAN CARE LABORATORIES, Dehradun) as Assistant
Manager- International Business & Regulatory Affairs April 2015 to Present
Job Responsibilities-
1) Developing Business Plans/ Market strategies for the products within the assigned
portfolio.
2) Discuss probable strategies / opportunities with the clients.
3) Client calling & rapport building with clients.
4) Documents preparation and submission for Tenders & Review of Tenders where company
can participate.
5) Independently handling client relationships & Search for prospective Clients in various
countries (New client acquisition).
6) Review of dossiers.
7) Co-ordinate with designers for Artwork development for various countries.
8) Co-ordinate with distribution, Production planning, manufacturing, and finance to ensure
timely availability of products.
Currently, Dealing with Clients Independently in the following countries:
Senegal
Mali
Maurtiania
Gabon
Djibouti
RESUME
2. PERSONAL DATA
Date ofBirth
24th
July, 1988
Father’s name
Mr. Udai Bhan Patel
Mother’s Name
Mrs. Meera Patel
Languages Known
English, Hindi
Gender
Male
Nationality
Indian
Marital Status
Married
PAST INDUSTRIAL EXPERIENCES
VERVE HEALTH CARE LIMITED, NEW DELHI August 2014 to March 2015
(Corporate office of VERVE HUMAN CARE LABORATORIES, Dehradun)
_______________________________________________________________________
Sr. Executive Regulatory Affair
1) Preparation and Compilation of registration dossiers of Tablets/Injections in CTD /ACTD/
NeeS/country specific format for countries or regions listed below:
ASEAN- Hong Kong, Myanmar, Vietnam, Philippines, Cambodia
LATAM- Costa Rica, Guatemala, Peru, Paraguay, Nicaragua, El-Salvador
CIS- Ukraine, Belarus, Kyrgyzstan, Tajikistan, Kazakhstan, Uzbekistan, Georgia
Middle East- Saudi Arabia, Yemen, Syria
Western Africa- Niger, Senegal, Nigeria, Mali, Ivory Coast, Togo
Southern Africa- Botswana, Namibia
Eastern Africa- Ethopia, Rwanda, Mozambique, Uganda, Kenya, Madagascar,
Tanzania, Malawi.
Central Africa- Cameroon
Asian- Sri lanka, Mongolia, Bhutan
2) Preparation of Periodic Safety Update Report (PSUR).
3) Preparation of accurate and timely responses to queries received for regulatory
agencies.
4) Submission of Documents in CDSCO North Zone (Ghaziabad) office for the grant of
COPP.
5) To co-ordinate with Q.C., Production & R&D department (Dehradun Plant) for
preparation of Drug Dossiers of Pharmaceutical formulations
6) Preparation of Stability Report, Process Validation Report for COPP application
filing.
7) Planning for eCTD/NeeS submission.
8) Filing & Compilation of Tenders (International).
ARBRO PHARMACEUTICALS LTD., NEW DELHI March 2013 to July 2014
________________________________________________________________________
Regulatory Affair & QA Executive
1) Preparation and Submission of registration dossiers of Tablets/Capsules/Oral
Suspension in CTD/ACTD/country specific format for countries like Srilanka, Nigeria,
Hong Kong, Cambodia, Cameroon, Ukraine, Tajikistan, Belarus, Mozambique, Tanzania,
Vietnam, Myanmar, Trinidad and Tobago, Kyrgyzstan, Kenya, Phillipines, Kazakistan etc.
2) Prepare accurate and timely responses to queries received for regulatory agencies.
3) Checking & approval of artworks as per domestic market & specific country
requirement.
3. 4) Communicate and follow up with agent for progress of registration submission.
5) Maintaining & updating country wise registration status and arranging for renewal
6) Monitoring & maintaining stability studies data.
7) Sending samples to Public testing lab for analysis.
8) To co-ordinate with Q.C., Production & R&D department for preparation of Drug
Dossiers of Pharmaceutical formulations
9) Preparation of Stability Report, Process Validation Report for COPP.
10) Preparation of sample for registration in various countries. Solve queries regarding
dossiers.
11) Handling market complaints.
12) Preparation of SOP’s for different departments.
13) To conduct reference study search in libraries / internet for accumulating comparative
technical data of various Formulations.
14) To check the Batch manufacturing records and documentation systems for dossier
Preparation.
ARBRO PHARMACEUTICALS LTD., NEW DELHI September 2012 to February
2013
Trainee Regulatory affair
1) Preparation of Modules of Dossiers for ASEAN Market (ACTD Format).
2) Checking of Dossiers.
3) Solving issues related to dossiers.
4) Handling & solving of Client Requirements.
5) Familiar with various Regulatory Guidelines.
EDUCATION QUALIFICATIONS
MBA in International Business from Sikkim Manipal University (Distance Education)
–Pursuing (3rd Sem).
M. Pharm (Gold Medalist) in Drug Regulatory Affairs & Pharmaceutical Management
from School of Pharmaceutical Sciences, Jaipur National University, Jaipur with
74%.(2013).
Completed B.Pharm from I.T.S. Paramedical College (UPTU), Ghaziabad with
66%.(2011).
Completed intermediate with 70% from Noida Public Sr. Sec. School (C.B.S.E board)
in 2005
Completed high school with74% from Noida Public Sr. Sec. School (C.B.S.E board) in
2003.
4. PROJECT WORKS
Project in B. Pharmacy – ROLE OF REGULATORY & PHARMACOVIGILANCE
IN SAFETY OF MEDICINES.
Project in M. Pharmacy – A COMPARATIVE STUDY OF PHARMACEUTICAL
PRODUCTS REGISTRATION FILING IN ASEAN, EUROPEAN UNION AND
INDIA.
DECLARATION: - I hereby declare that above information are true in my best of knowledge
Date :
Place: ANUPAM PATEL