Assistant Manager - Regulatory Affairs (US Market)/Formulations OSD

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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