- Responsibilities to be handled for ROW markets:
Co-ordination with all the parties for ongoing and new product submissions
To prepare & review registration dossiers in ACTD, CTD for Africa, Latam, South East Asia, Middle East & PIC/S countries.
To Study, the guideline for product registration thoroughly, ensure product registration of dossiers as per the guidelines, compilations of data and arranging specific data required for registration.
Timely submission of Technical Documents, Tender Documents, and LOA to procurement agencies.
Prepare the various Applications like Mfg. Lic, Product permission, free sale certificate, COPP, Domestic Tender Documents, Chemist Approval to Food and Drug Administration in Time.
Liaoning with state FDA, CDSCO, DCGI- for manufacturing licenses, export licenses
Agreements To draft, review & comment on the Distribution, Promotion, Agency, MOU Plan
Technical Support to Head International Business/Director for the business development. Technical support to the International Marketing Department.
To update the working status of Regulatory department & to keep control on Regulatory work.
Customer Complaint: Domestic and International - Final answers to send to respective departments for sending to customer.
- Responsibilities to be handled for Regulated markets:
Filing of dossiers in regulated markets complying with the requirements of European Union, USFDA, TGA, Canada, Brazil and ROW countries in CTD & eCTD formats.
Filing of major & minor variations and notifications to regulatory agencies ( Site variation, Change of API, changes in the formulation, changes in labeling & packaging etc)
Guidance to technical team for regulatory change management
Deficiency / query responses to regulatory agencies from Regulated & ROW markets
Liaoning with regulatory bodies for filing of generic products (ANDAs) with EU countries, USFDA, Health Canada, TGA
Training team on regulatory guidance, updates
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