Team Member – Regional RA | Cipla | Mumbai

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Job Overview

  • Date Posted
    October 29, 2023
  • Location (State / UT)
  • Expiration date
    November 14, 2024
  • Experience
    2 Years, 7 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Job Purpose:

Submit product documents to regulatory authorities in accordance with country-specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the product life-cycle

Role & responsibilities:

  • New Marketing Authorisation Application and Maintenance of European Marketing Authorizations belonging to the Cipla group of companies in accordance with EU legislation.
  • Submission to the approval of regulatory procedures viz. New MAA, variations, renewals, sunset clause, and process licenses (MIA) by collaborating with Central Operations teams / Cross-functional teams in line with business plans and with EU legislation.
  • Participating in forums discussing product supplies in collaboration with cross-functional teams, providing regulatory input to achieve on-time launch and uninterrupted supplies to the market in line with business plans.
  • Maintain files/databases to reflect up-to-date filing to approval status by having internal systems to capture these online so that the business / cross-functional teams have visibility of submission to approval status of the region. Report MA approval and updates to PV within timelines to allow compliance with PV legislation.
  • Support Group Leader/Team Leader-Europe in leadership reviews and discussions.
  • Attend training as scheduled in order to ensure the successful filing of Regulatory applications.
    Other works assigned by department heads.
Education Qualification & Relevant Work Experience

B. Pharmacy , M. Pharm, BSc or MSc with minimum 2 years of experience in regulatory activity in the Pharma Industry worked for Europe region/authority