4 - 5 years
0 Lacs
Posted:3 days ago|
Platform:
On-site
Full Time
Support RA Team and contribution in regulatory activities in order to achieve the objective of the department.
1. Global Product registration
2. Lifecycle management of the registered products
3. Compilation and update of dossiers for ROW market
4. Arrange and review CMC data required for dossier preparation.
5. Arrange documents of variation applications whenever required.
6. Assist in the co-ordination of response to the queries raised by Regulatory Authorities.
7. Coordinate with internal departments for documents and sample arrangement.
8. Prepare Product Questionnaire
9. Prepare and review the Draft Artwork, SMPC and PIL as per Country specific Regulatory guidelines & client requirements
10. Keeping updated information of relevant new/draft regulation/guidelines of global Regulatory Authorities including post approval requirements.
11. Prepare applications for legal documents-Product Approval, CoPP, FSC, renewal of WHO GMP & Mfg. Licenses.
12. Update all regulatory data related to activities to ensure RA workplan and Market Authorization database up to date.
13. Strong Listening and communication skills are required.
PIL-PSYCHOTROPICS INDIA LIMITED
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