regulatory affairs US market

3 - 8 years

7 - 9 Lacs

Posted:8 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Hands on experience in ANDA compilation & submissions with knowledge on review of CMC documents with review of bio-study data. Hands on experience in navigating the eCTD tools - Educe/Lorenz and/or Pharma Ready. USFDA guidance’s experience must

Required Candidate profile

Review and approve drug product commercial artworks for product launches, experience in navigating the eCTD tools Educe/Lorenz/ Pharma Ready. Injectables, Ophthalmics, Topicals, Nasal Sprays, OSD

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Opportune Solutions logo
Opportune Solutions

Consulting

Houston

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