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AGM-GRA (Regulatory Affairs) Kashiv BioSciences, LLC

12.0 - 16.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Maste...

Posted 1 week ago

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