RA Expert

ob description:

Dossier preparation compilation and timely submission of products in regulated countries.

Dossier compilation in ICH CTD eCTD ACTD and Country specific requirements.

Coordinate with the concerned departments regarding documents for dossier preparation.

Tracking of Dossier submitted to country and making updates & Controlling the whole process of registration of the product from beginning till the end.

Preparation and submission of Company Registration Documents.

Obtaining Product Registration Certificates

Maintaining Guidelines and checklists.

Performing final technical quality review.

Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;

Performing postsubmission processing activities such as receiving acknowledgement from authority of submission receipt; capturing of the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders;

Coordination with client/stakeholders