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.