Debojyoti Adak, PMP

Regulatory Affairs Manager at Quest Nutra Pharma Group
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Contact Information
us****@****om
(386) 825-5501
Location
Dubai, United Arab Emirates, AE
Languages
  • Bengali Native or bilingual proficiency
  • Hindi Professional working proficiency
  • English Full professional proficiency
  • Arabic Elementary proficiency

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Surajit Bhattacharya

Debojyoti is a person having strong determination to grow and highly flexible to cope up with any situation. A deserving candidate for any organization.

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Credentials

  • Become a Six Sigma Yellow Belt
    LinkedIn
    Oct, 2021
    - Nov, 2024
  • Becoming a Six Sigma Green Belt
    LinkedIn
    Oct, 2021
    - Nov, 2024
  • Six Sigma Black Belt
    Project Management Institute
    Oct, 2021
    - Nov, 2024
  • Project Management Foundations: Teams
    LinkedIn
    Sep, 2021
    - Nov, 2024
  • Six Sigma: Green Belt
    LinkedIn
    Sep, 2021
    - Nov, 2024
  • Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)
    Certified Clinical Research Professionals Society (CCRPS), Florida, USA
    Sep, 2021
    - Nov, 2024
  • Project Management Professional (PMP)
    Project Management Institute
    Dec, 2022
    - Nov, 2024
  • Project Management Professional (PMP)®
    Project Management Institute
    Dec, 2022
    - Nov, 2024
  • RAPS Member
    Regulatory Affairs Certification Program
    Dec, 2020
    - Nov, 2024

Experience

  • Quest Nutra Pharma Group
    • United Arab Emirates
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Manager
      • Jan 2021 - Present

      𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Developing strategies to ensure the company registration activities comply with government regulations.❖ Serving as a liaison between regulatory bodies and operating divisions of the company.❖ Responding to queries from regulatory bodies.❖ Coordinating with operations departments regarding the latest regulatory update to ensure compliance with regulations.❖ Monitoring and updating the product registration status.❖ Tracking the internal changes through Vivaldi/Kiss-flow system to update the changes to the regulatory authorities through variation submission.❖ Submission of dossiers to GCC, MENA, CIS, Asia, Africa & Europe region.❖ Reviewing the required documents for dossier preparation e.g., Artwork, Drug Master File, Analytical Method Validation, Process Validation, Certificate of Analysis, Specifications, Stability data and report, Bioequivalence, etc. as per guideline.❖ Supporting the customers with their required documents on time.❖ Maintaining an informed awareness of regulatory guidelines and constant updating of information to new guidelines.❖ Identifying labelling issues as errors, inconsistencies, conflicts, etc., between package leaflet text statements and SmPC and acting decisively to solve such issues.❖ Co-ordinating with QPPV to Establish & maintain the Pharmacovigilance system in QNP.❖ Preparation of post-meeting files including Quality Control file and Stability file.❖ Preparation of the file for the registration of general sales products.❖ Monitoring the progress of all registration submissions. Show less

    • Pharmacovigilance Deputy Manager
      • Oct 2021 - Present

      𝑲𝒆𝒚 𝑹𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒊𝒆𝒔 -❖ Co-ordinating with QPPV to Establish & maintain Pharmacovigilance system in QNP.❖ Preparation, revision and responsible for submission of all Pharmacovigilance documents (PBRER, RMP, ACO, DHPC) to MOHAP UAE within the specified time frames.❖ Routine Literature search to follow any updates on owned Products.❖ Maintain Safety data exchange agreement.❖ Have an Overview of the Risk Management Plans.❖ Collect Case Safety reports and report them to health authorities within the specified timeframe. Show less

Education

  • Seemanta Institute of Pharmaceutical Sciences (SIPS), Jharpokharia, Mayurbhanj,
    M. Pharm, Pharmaceutical Chemistry
    2009 - 2011
  • Institute of Pharmaceutical Management
    Post Graduate Diploma in Regulatory Affairs, Regulatory Affairs (API & Formulation)
    2014 - 2015
  • Institute of Pharmacy, Jalpaiguri, WB, West Bengal University of Health Science
    Bachelor of Pharmacy (B.Pharm.), Pharmacy
    2004 - 2008
  • KTPP HIGH SCHOOL, WEST BENGAL
    HIGHER SECONDARY, SCIENCE
    2001 - 2003
  • Bhogpur Kenaram Memorial High School, Purba Medinipur, West Bengal Board of Secondary Education
    Secondary (10th Standard), English, Life Science, Physical Science; Mathematics, History, Geography, Physics (Addl)
    1996 - 2001
  • Carreograph Institute of Management Studies, Vidyasagar University
    Master of Business Administration (MBA), Pharmaceutical Industrial Management
    2010 - 2012
  • Federation of Indian Chambers of Commerce and Industry
    Certificate Course on IPR and Pharmaceutical R&D(CCIPR), IPR and Pharmaceutical R&D(CCIPR)
    2018 - 2018
  • RAAJ Pharma eLearning
    PGD-GRA, Global Regulatory Affairs
    2018 -

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