Regulatory Affairs CMC ANDA submissions Executive or Sr Executive

4 - 8 years

7 - 8 Lacs

Posted:5 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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

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Opportune Solutions

Consulting

Houston

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