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    Curriculum Vitae

    Jatin ThakralH. No. 382,

    Sector - 40,NOIDA

    India.

    Mobile: 9310698476

    E mail: [email protected]

    Career Objective

    To be associated with a progressive organization which can provide me with a dynamic work space to extract my

    inherent skills as a Professional, use and develop my aptitude to further the organizations objectives and also

    attain my career targets in the progress.

    PRESENT WORKING

    Working as REGULATORY AFFAIR OFFICER in Drug Regulatory Affair Department in Maharishi Ayurveda

    Pvt. Ltd. Plot number 16 17, NSEZ, Noida from July 2010.

    JOB DESCRIPTION

    1. Working on Project of THMPD Registration of Two Herbal Products (Tablets) in EU market, in

    collaboration with Department of AYUSH, Himalaya Drugs, Dabur India Ltd.

    2. Complied dossier for various ROW countries like Ukraine, Philippines and South-Africa etc.

    3. To ensure Regulatory Compliance by approving the Operational Documents in line with regulatory

    Commitments.

    4. Extend support to Corporate Regulatory by ensuring timely availability of necessary documents for new

    submissions, annual reports, renewals and re-registration.

    5. Participation in Regulatory Inspections & QA/QC lab Audits.

    6. Provide necessary regulatory support to Manufacturing Location to ensure uninterrupted manufacturing

    of new and already existing products considering all requirements of regulatory compliance.

    7. Document Review like Specifications, STPs, BMRs, Stability Studies, Preparation of Mock ups, Art

    works, SPC and DMF.

    8. Preparation of Dossiers filling check list.

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    Education Qualification

    Examination / Degree Stream / SubjectName of Board/ University

    (College)

    Year of

    Passing

    Division

    M .Pharmacy PharmacognosyPunjab Technical University (I.S.F.

    College of Pharmacy-Moga)2010 FIRST

    M.B.A.International

    businessG.J.U (Distance Education) 2011 Pursuing

    PGDIPR Regulatory affairs IGNOU 2009 First

    B. Pharmacy Pharmacy K.U.K 2007 FIRST

    Higher secondary Medical H.B.S.E 2002 First

    Summary of Professional Experience

    Eighteen months working experience With INTAS PHARMACEUTICALS as A Territory Business Manager.

    Skills

    A flexible & detail oriented attitude with an ability to work independently as well as part of a

    multidisciplinary team.

    Well versed with MS Office, Design Expert 8 and Internet Applications.

    Having Knowledge of Registration and Documentation Requirements for import /export of Medical

    Devices.

    Knowledge of Regulatory Guidelines (ICH, Eudralex, CHMP, 21 CFR Guidelines)

    Project Handled

    Bioactivity guided fractionation of methnolic extract of c. Arvensis with special emphasis on anticancer

    activity.

    Tumor tissue targeting using drug (anticancer)

    Publications / Presentations

    Paper published on Drug regulatory affairs in india Pharmaspire.

    Paper published on Geographical indication. Pharmaspire.

    Paper published on intellectual property rights in Pharmaspire

    Paper published on ANTI OXIDANT ACTIVITY OF C. ARVENIS in international journal of

    pharmaceutical science and drug research.

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    Paper published on ANTI MICROBIAL ACTIVITY OF C. REFLUXA. In J. of Pharmacognosy.

    Conference /Work shop Attended

    Work shop (Ten days) on ICH GCP guidelines on registration of pharmaceutical products for humanuses with special emphasis on module 3-5, given by BIO-MANTRA, at Maharishi Ayurveda Noida.

    Silver Jubilee conference of IPGA, I.S.F. College of Pharmacy, Moga, 7 th & 8th November 2010.

    Nano-Collloidal carriers: Site specific & controlled drug delivery, I.S.F. College of pharmacy, Moga, Oct

    10th & 11th October 2008.

    Personal Details

    Fathers Name : RAMESH THAKRAL

    Date of Birth : 17-FEB-1985

    Gender : Male

    Marital Status : UnmarriedNationality : Indian

    Language Known : Hindi, English, PunjabiPassport number : G2380060

    ACADEMIC REFERENCE:-

    DR. A.N KALIA

    Professor

    HOD Department of Pharmacognosy

    ISF College of pharmacy, Moga

    Punjab, INDIA

    INDUSTRIAL REFERENCE

    1. Mukesh Saini, Deputy Manager, IPR, Venus Remedies Ltd., 51-52Industrial Area, Phase-I, Panchkula.

    2. Virender Kumar, Research Scientist, Drug Regulatory Affairs -EU, Jubilant Life Science Ltd. Noida

    3. Dr V. K Singh, General Manager - QA/QC, Maharishi Ayurveda Pvt. Ltd, Noida.

    DATE: March-2011 Jatin Thakral

    PLACE: NOIDA