07 Aug
|
Randstad
|
Hyderabad
07 Aug
Randstad
Hyderabad
First-time filing experience: hands-on authoring, review, and submissions for initial filings in the US and EU
(e.g., IND, ANDA, NDA, BLA, MAA).
Health authority queries: hands-on management, including data gathering and drafting of responses.
Source data review: hands-on review of source data from R&D;, manufacturing, and related functions.
Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.
experience 10
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📌 Associate Regulatory Affairs Hyderabad
🏢 Randstad
📍 Hyderabad