10 - 14 years
6 - 8 Lacs
Posted:None|
Platform:
Work from Office
Full Time
1. Preparation of Drug Master File for US, EU and Row countries according to year plan.
2. Preparation and submission of Annual Reports, Amendments and updates to filed DMFs.
3. Preparation and Submission of responses to queries from customer and regulatory authorities.
4. Preparation of Technical information package (TIP) based on customer requirement.
5. Adequacy review of documents required for Drug Master File & TIP preparation like BMR, process validation reports etc.
6. Coordination with R&D, Quality Control and Quality Assurance to collect required documents.
7. Evaluation of impact of changes to the submitted DMF’s.
Only API - Industry Experience candidate required.
Cdymax India Pharma
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