Asst. Manager, US Regulatory Affairs

6 days ago

Industrial Area, India Jubilant Generics Limited Full time

Job Summary: Drug dossier authoring, reviewing & submission drug product application.Management of product life cycle management (LCM) activities.Assessment of post approval changes to secure successful product approvals & LCM.Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.Key Responsibilities:Drug dossier authoring, reviewing & submission of ANDAs (US).Product life cycle management (LCM) activities.Assessment of post approval changes.eCTD publishing.Thorough knowledge of CMC and Module 1 requirements.DMF review and assessment, Query evaluation and response for under review ANDAs within timeline.Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities.Artworks (PIL, labels) and labeling files preparation, submission along with SPL preparation.Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities.Review and finalization of artwork / label as per current guideline.Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner.Co-ordination with API vendors to resolve technical quires w.R.T. regulatory requirements.To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D / ADL against DMF / Dossier requirements.Maintain regulatory files / database.

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