Executive DRA - ROW

Collaborate and manage all relevant regulatory activities related to registration of product in ROW (Rest of World) Conturies.

(Dossier, preparation / compilation & submission of assigned dossiers, MOH / Consultant query response admin documents working as well as samples working.

Ensure commercial batches are manufactured and labeled as per the approved documents.

Responsible for working on the prior assessment variation dossier, renewal planning and gap analyzing of registered dossiers with current master for ROW region.

Responsible for review of dossiers assigned by the team lead if any

Responsible for initiation of renewal and registration intimation form to QA/ QC closely work with QA/QC for variation assessment of registered dossier for ROW region.

Coordination & continuous follow up with all department QC, QA Artworks production & purchase and tracking of target date deviation with proper justifications for ROW region or any other country.