Job Overview
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Date PostedAugust 30, 2022
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Location (State / UT)
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Expiration dateJanuary 15, 2027
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Experience5 Years
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GenderAny
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Desired QualificationBachelor 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
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