Team Member – Regional Regulatory Affairs | Cipla | Vikhroli

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:

I. 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 the 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.
III. Maintain, and update product dossier as required to meet changes in Cipla’s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
IV. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in the database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the informatuitability and availability of the 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 of experience in regulatory activity in the pharma industry preferably working for the same region/authority