Team Member – Regulatory Affairs | Cipla | Mumbai

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

Accountabilities

  • Achieve timely submission of dossier/DMF and deficiency responses to the regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
    II.
  • Submit post-approval variations for changes that improve productivity, cost-effectiveness, and quality of the product by reviewing, collating, and compiling the variation application to meet the delivery within timelines and maintain
  • Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorizations.
  • Maintain, and update product dossier as required to meet changes in Cipla’s internal systems, changes in regulatory guidelines, and to meet the need for regulatory requirements
  • Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in the database.
  • Provide Regulatory support throughout the life cycle of the product for smooth functioning
  • Provide the information usability and availability of dossier for out-licensing and in-licensing
    VII. Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done
Education Qualification

B.Pharmacy, M. Pharm, BSc or MSc

Relevant Work Experience

Minimum 5 years experience in regulatory activity in the pharma industry preferably worked for the same region/authority

Location