Posted:8 hours ago|
Platform:
Work from Office
Full Time
Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years).
Submission of new submissions, deficiency responses and/or post-approval submissions for above markets.
Worked on various dosage forms including complex generics.
Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections.
Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections.
Hands on experiance for ECTD compilation.
Lupin
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