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:

Ritika.Prasad@amneal.com




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