Company: Cipla Ltd
Education Qualification: B.Pharm, M.Pharm, B.Sc or M.Sc
Relevant Work Experience: Minimum 5 years experience in regulatory activity in pharma industry preferably worked for same region/authority.
Location: Vikhroli
Division: R&D
Department: Regulatory Affairs
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 products life-cycle
Accountabilities
I. Achieve timely submission of dossier/DMF and deficiency responses to 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 improves productivity, cost-effectiveness, quality of the product by reviewing, collating, 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 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 database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the information 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
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