Pramod kumar Patra

Manager Regulatory Affairs at RAPTAKOS BRETT & CO.
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Contact Information
us****@****om
(386) 825-5501
Location
IN
Languages
  • English -
  • Hindi -
  • Odia -
  • Marathi -
Skills

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5.0

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Kajal Shah

Pramod’s ability to deal with multiple projects with patience & dedication is definitely commendable! And his technical skills and knowledge will definitely always take him higher!

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Credentials

  • Regulatory submission as per CTD-eCTD
    Raaj GPRAC PVT LTD
    May, 2022
    - Nov, 2024
  • WIPO
    World Intellectual Property Organization
    Sep, 2011
    - Nov, 2024

Experience

  • RAPTAKOS BRETT & CO.
    • Research Services
    • 300 - 400 Employee
    • Manager Regulatory Affairs
      • Nov 2022 - Present

  • Unosource Pharma Ltd.
    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Manager Regulatory Affairs
      • Apr 2022 - Nov 2022

    • Assistant Manager
      • Apr 2019 - Mar 2022

      Drug registration in entire East-Africa and French West Africa as per CTD and country specific guidelines along with query response.

    • Sr. Executive Regulatory Affairs
      • Apr 2017 - Mar 2019

      Drug registration in entire East-Africa as per CTD and country specific guidelines along with query response. Preparation of PSUR (Periodic Safety Update Report) and RMP (Risk Management Plan) as per EMA guidelines for CIS countries. Review of master CTD, Gap analyses and Artwork assistance. Also assisting International Tenders.

    • Executive Regulatory Affairs
      • Apr 2015 - Mar 2017

  • Charak Pharma Pvt. Ltd.
    • India
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Regulatory Affairs Executive
      • Jun 2014 - Mar 2015

      Herbal product registration in as per CTD, ACTD and country specific guidelines. Herbal product registration in as per CTD, ACTD and country specific guidelines.

  • Wintech Pharmaceuticals, Dadar T.T
    • Officer Regulatory Affairs
      • Jul 2012 - Jun 2014

      Regulatory Department • prepared dossiers for Vietnam, Thailand, Nigeria, Srilanka. • Preparation of PV, SS. • Outsourcing of dossier documents like DMF, AMV, etc. Food & Drug Administration Documentation • Product license Application • COPP Application • FSC Application • Market standing • Export NOC • Documentation related to Manufacturing license renewal and WHO renewal. • Tender Documentation (Export & Domestic) • Export Tender: Bhutan, Srilanka etc. • Local Tender: BMC, Assam, Kerala, Tamilnadu, Delhi, Karnataka etc. • Artwork checking Show less

  • ciron drugs & pharmaceuticals ltd.
    • jogeswari
    • trainee Regulatory Affairs
      • Mar 2012 - Jun 2012

      FDA documentation FDA documentation

  • GLENMARK,NALAGARH
    • PROJECT TRAINEE(M.pharm)
      • Dec 2010 - Apr 2011

      m.ph project work on process validation. m.ph project work on process validation.

Education

  • Shri Jayadev College of Pharmaceutical Sciences Biju Patnaik University of Technology
    M. Pharma, Pharmaceutics
    2009 - 2011
  • Institute of pharmacy & technology Biju patnaik University of Technology
    B. Pharm, Pharmacy
    2005 - 2009
  • Salipur College,Salipur
    12th, Physics
    2001 - 2003
  • Handidhua Highschool,Talcher
    Matriculation
    1996 - 2001

Community

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