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Executive, Regulatory Affairs at Amneal India

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

07 Jun, 26

Salary

0.0

Posted On

09 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, CTD Preparation, ACTD Preparation, Dossier Preparation, Regulatory Guidelines, Technical Document Review, CFT Collaboration, Product Tracking, Gap Analysis, Filing Strategy, Query Handling, Database Maintenance, Master Dossier Archiving, Change Control Assessment, Project Management Support

Industry

Pharmaceutical Manufacturing

Description

To prepare quality CTD, ACTD and Country Specific Dossier as per the regulatory guidelines of AFRICA/MENA/LATAM/CIS/ASEAN Market.  Review of technical documents of PD, ARD, QA, QC, Production to include as a part of dossier and actively working with all the CFTs for regulatory and all administrative documents and track and trace each product.  Preparation 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 finalizing product filing strategy for different phase of international market submission to immediate supervisor / HOD.  Handling Queries of submitted dossier arising from regulatory authorities.  To Prepare, update, periodically maintain different database trackers & status.  Review and archiving each product’s master dossiers, documents and ensure to keep update for the same.  Constant follow up with all CFT for regulatory submission documents.  Registration samples/ artworks-mock ups arrangement and dispatch with support of project management lead post dossier submission.  Review & Assessment of change controls for AFRICA/MENA/LATAM/CIS/ ASEAN Markets products execution.  To provide accurate, current & up to date status to immediate supervisor as & when required.  To Support superior for assigned task on day-to-day basis.  Other duties as assigned by immediate supervisor/HOD.

Responsibilities

The role involves preparing regulatory dossiers (CTD, ACTD, Country Specific) for various international markets including AFRICA/MENA/LATAM/CIS/ASEAN, and actively reviewing technical documents from PD, ARD, QA, QC, and Production for inclusion in these submissions. Responsibilities also include handling regulatory queries, maintaining databases, assessing change controls, and coordinating submission logistics like sample arrangements.