Amneal Pharmaceuticals Hiring For Strategic International Expansion Regulatory Affairs
Department: Strategic International Expansion Regulatory Affairs
Designation: Assistant Manager
Location: Ahmedabad
Qualification: Any Discipline
Experience: 10-15Yrs of expereince
Job Description :
• Must have experience of China Market.
• Preparation and review of preliminary product gap analysis report to confirm feasibility & suitability of US approved
products which are leveraging to international markets.
• Preliminary due diligence and support in finalize product filing strategy for different phase of international market
submission to immediate supervisor / HOD.
• Actively working with all the CFTs for regulatory and all administrative documents and track and trace each product.
• Preparation, compilation and review of IDL application, CTD, ACTD and eCTD dossier for international markets.
• Providing registration dossier and communication with various international partner for final submission and further
course of action.
• Archiving filed dossiers and listing down open points for each project.
• Review & preliminary assessment of change controls for market specific products execution.
• Preparation of preliminary regulatory strategy and handling deficiency response.
• Review of technical documents of PD, ARD, QA, QC, Production to include as a part of dossier.
• Communicate and co-ordinate with Project Management team for product execution activities.
• Support to superior for assigned task on day-to-day basis.
• Other duties as assigned by HOD.
Interested candidates can share their CV with subject as “Regulatory affairs CV “on mail ID:
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