8 to 12 Years
Healthcare / Medical / Hospital
Functional Area
Medical Professional / Healthcare Practitioner / Technician
Job Profile/Required Experience
1. Experience of preparing, review and submission eCTD.
2. Experience on deficiencies, post approval changes activities.
3. Experience on SUPAC, Variation filing.
4. Review of Technology Transfer documents from R&D to Mfg facility
5. Review of PDR, MFC, and Pre exhibit batch proposal.
6. Review and authorize BMR, BPR and PV documents, Change control, deviations and post approval Mfg changes.
7. Review of CTD related documents Intended batch records, proposed batch sizes.
8. Review and approve OOS, OOT, and CAPA, periodic and skip test items, In-process checks, annual reports, Product recalls, Stability documents etc.
9. Experience on internal presentation to Management and Task force committee - strategy for registering the product in various markets.
10. End to end understanding of regulatory procedures for registering a product in US, Europe and Rest of the world.
11. Manage the changes during the life cycle of the product
12. Managing and coordinating various regulatory activities throughout the life cycle of the project/product

Alloys consulting pvt ltd
Alloys consulting pvt ltd
B-8, Cabin No -9, 38 ansal tower , Nehru place
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