4 - 7 years
5 - 9 Lacs
Posted:1 month ago|
Platform:
Work from Office
Full Time
Alembic Pharmaceuticals Ltd is looking for a Regulatory Affairs professional for the position of Executive / Sr. Executive based at our Corporate Office - Vadodara, Gujarat. Job Criteria: B.Pharm or M.Pharm qualification having experience between 4 - 8 yrs. with dossier filling experience in Europe & South Africa Countries. Knowledge for review of quality documents like executed batch documents, method validation, change Good communication skills. Job Description: Review of product initiation form /extension form Review of technology transfer documents Dossier compilation / periodic updates in dossier checklist CTD/NeeS/eCTD Submission & correspondence with agency / customer CoPP Dossier online review, submission with customer / agency & assessment phase Post approval life cycle management i.e. variation, renewal, updated dossier, variation status Interested candidate can share cv on creyesha.macwan@alembic.co.in
Alembic Pharmaceuticals
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