Team Member – Regulatory Assurance & Training | Cipla | Vikhroli

HR / Admin / Office, PharmacoVigilance / Regulatory Affairs
Maharashtra
July 8, 2023
Full Time
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Job Overview

  • Date Posted
    July 8, 2023
  • Location (State / UT)
    Maharashtra
  • Expiration date
    August 7, 2025
  • Experience
    3 Years, 5 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Job Purpose

Execute the regulatory assurance and training processes by maintaining RA documentation systems, tracking regulatory commitments and annual report submissions to achieve regulatory assurance for Cipla

Accountabilities

  • Check the regulatory commitments from Registration, Variations, and Renewals till closure by continuous tracking and following defined procedures to achieve compliance with regulatory filings.
  • Check timely submission of Annual Reports for all formulations and API registered with the US market through defined procedures to meet compliance with US regulatory requirements.
  • Gather the impact of Import Alerts to registered API manufacturers and collate the impact assessment to ensure timely submission to CQA.
  • Check timely submission of Biannual Reports to Canada & annual reports for South Korea DMF and WHO APIMF to meet compliance with regulatory requirements.
Education Qualification

B Sc./ MSc / B. Pharm / M. Pharm

Relevant Work Experience

3-5 Years of experience in quality or regulatory

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