debojyoti adak,

debojyoti adak

Location
United Arab Emirates - Dubai
Education
High school or equivalent, Pharmaceutical Chemistry
Experience
9 years, 2 Months

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Work Experience

Total years of experience :9 years, 2 Months

  • My current job since January 2021

Quest Nutra - Regulatory Affairs Manager

Regulatory Affairs Officer at National Pharmaceutical Industries Co, SAOC
  • Oman - Muscat
  • November 2016 to January 2021

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 labeling 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

at Group Pharmaceutical Limited
  • September 2012 to November 2013
at Malur
  • India
  • November 2011 to April 2012

Education

High school or equivalent, Pharmaceutical Chemistry
  • at West Bengal University of Health Science
  • January 2023
Bachelor's degree, PMI
  • at PMPInstitute of Pharmaceutical
  • January 2019

courses: Certified Project Management Professional (

Master's degree, Pharmaceutical IndustrialManagement
  • at Vidyasagar University
  • January 2013
High school or equivalent, PMI
  • at PMPInstitute of Pharmaceutical
  • January 2012

courses: Chambers of Commerce & Industry (FICCI) India Certificate course on Intellectual Property Right

High school or equivalent, Pharmaceutical Chemistry
  • at Biju Pattnayak University of Technology
  • January 2008

Specialties & Skills

Languages

Arabic
Beginner
English
Expert
Hindi
Expert