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Regulatory Affairs CMC ANDA submissions Executive or Sr Executive Opportune Solutions

4.0 - 8.0 years

7 - 8 Lacs

nelamangala

Work from Office

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products

Posted 9 hours ago

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