Regulatory Affairs Officer | Gufic Group | Navsari

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Job Overview

  • Date Posted
    July 27, 2023
  • Location (State / UT)
  • Expiration date
    --
  • Experience
    2 Years, 4 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

  • Provide samples & documents for regulatory filing to the regulatory department at HO & regulatory department of outside parties.
  • Coordination with QC/Production/QA/ F & D for documents related to the dossier.
  • Coordination with QC/ Production /QA/ F & D for samples & working standards for providing HO & regulatory department of outside parties.
  • Review the documents received from QC/PRODUCTION/QA/ F & D before providing them to the regulatory department at HO & other parties.
  • Coordination with HOD for replying to the queries received from parties and MOH.
  • Preparation of therapeutic category master and formula master & product master of third party & own products of All Units (Injectables/ Ayurvedic/ Allopathic ointment) & other Unit.
  • Collection of data from QA, QC, BSR, Production & HO for formula master & product master creation of third party & own products of Units.
  • Coordination with all Unit stores & HO for material codes required for creating BOM.

Desired Candidate Profile

  • Good In Communication
  • Documents handling.
  • Accurate Filing

Qualification: B.Pharma, M.PHarma