12 - 15 years
15 - 25 Lacs
Posted:2 weeks ago|
Platform:
Work from Office
Full Time
1. Extensive experience in Regulatory Affairs for EU Market.
2. Strong knowledge of CMC (Chemistry, Manufacturing, and Controls) document review processes.
3. Experience in the DCP and Variations procedures and management end to end.
4. Experience using regulatory submission tools like Lorenz DocuBridge or other eCTD software.
5. Excellent communication skills, both written and verbal, in English. Proficiency in other languages (preferred but not required).
6. Detail-oriented, highly organized, with a strong ability to manage multiple projects and meet tight deadlines.
7. Proven track record of successful regulatory submissions and approvals in EU markets.
8. Up-to-date knowledge of global regulatory environments and trends, particularly in the EU markets.
Althera Laboratories India Pvt Ltd, Bangalore
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