Bindu John

Experience

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  Rula Pharmacy

  Oct 2000 - Feb 2002

  Pharmacist
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  American Mission Hospital

  Mar 2002 - Oct 2015

  Pharmacist
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  Yousuf Mahmood Husain, Bahrain

  Apr 2016 - Mar 2023

  Regulatory Affairs Associate

  Handle all regulatory activities for Pfizer, Novartis Pharma, GSK consumer health care, Johnson & Johnson Medicines and Consumer, Eli lilly, Boehringer Ingelheim, Sanofi Aventis, Baxter and Roche.Responsible for preparing, compiling, Submitting registration documents for all new and existing medicines, monitoring submission to regulatory authorities and addressing all issues raised in regulatory review process.Responsible for preparing files as per NHRA requirements for product license renewal, product variation, site registration and renewals.Support the development of timelines for CTD and eCTD submissions via /approval to minimize any delays.Guide principal regulatory teams to prepare the specific documents for submission as per NHRA regulations.Follow up with principal companies for Authority IRF’s until file is approved.Product license Expiry evaluation for the principals and follow ups.Apply for Import permit application of narcotics & Controlled Drugs via new online system ‘’DUR’’ .Update the GPRS portal for Roche productsAttend Regulatory / Pharmacovigilance annual trainings provided by the principal companies. Show less

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  HTP Group

  Jan 2023 - now

  Regulatory Affairs officer Pharmacist

  pharmaceutical