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Amgen Technology Private Limited logo
Sr. Associate Regulatory Affairs Amgen Technology Private Limited

2.0 - 5.0 years

2 - 5 Lacs

Hyderabad, Telangana, India

On-site

Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation...

Posted 3 months ago

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