Assistant Manager - Regulatory Affairs; US Market​/Formulations OSD

Position: 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.