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

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

Jubilant Generics LimitedNoida, Uttar Pradesh, India
6 days ago
Job description

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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