Team Member – CDT | CIPLA | Vikhroli

HR / Admin / Office, PharmacoVigilance / Regulatory Affairs
Maharashtra
September 6, 2023
Full Time
Apply Now

Job Overview

  • Date Posted
    September 6, 2023
  • Location (State / UT)
    Maharashtra
  • Expiration date
    October 10, 2025
  • Experience
    5 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Job Purpose:

Compile dossier in accordance with regulatory strategy, manage deficiencies, evaluate products and submit tenders to ensure adherence to regulatory requirements for various regulated/international markets within agreed timelines

Accountabilities:

I. Review documents and compile and handover quality dossier as per enforcement of/updates in regulatory guidelines for various regulated/ international markets, so as to minimize deficiencies from the health authority
II. Evaluate and compile quality deficiency responses to all regions to meet the targeted timelines of the health authorities/customers.
III. Assess and submit product evaluation and tender documents to regional teams for DRF conversion and product commercialization
IV. Adopt and disseminate information on new regulatory guidelines through ongoing training and interaction with regional teams to minimize deficiencies

Education Qualification

Graduate/Post Graduate in Pharmacy or Life Sciences

Relevant Work Experience

5 years in the field of Regulatory Affairs/Quality Assurance

Related Jobs