16 Aug
|
Randstad
|
Hyderabad
16 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).2. Health authority queries: hands-on management, including data gathering and drafting of responses.3. Source data review: hands-on review of source data from R&D;, manufacturing, and related functions.4. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.experienc
📌 associate - regulatory affairs (Hyderabad)
🏢 Randstad
📍 Hyderabad