Executive, Regulatory Affairs

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.

M. Pharma