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Assistant Manager, Regulatory Affairs

Hcfa (CX_5001) · Ahmedabad City, Gujarat, India

Compliance & ContractsImported listingfull-time3 days ago

About The Role

  • Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals.
  • Working on due diligence projects for US, EU & Canada markets as per the business agreement.
  • Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions.
  • Preparation of project status, discussion slides & white papers as required for escalation & decision at different stages of the projects.
  • Assessment of change controls & providing necessary regulatory comments/approval.
  • Provide support in developing/updating regulatory tools, checklists, databases as per dept. needs.
  • Participate in project meetings, communication & coordination with CFTs.
  • Knowledge of relevant regulatory guidelines & updates is must.
  • Ability to perform under changing priorities, deadlines & regulatory expectations.
  • Skills like, technical writing, presentation, training, effective communication/coordination is preferred.
  • Experience of Nitrosamine risk assessment report review will add value.
  • A positive learning orientation to quickly adapt Amneal systems, RA tools & processes will add value.
  • Knowledge of using AI tools in routine work will add value.

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