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.