DRA Officer

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DRA Officer

work outline icon0 - 2 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Akums Drugs and Pharmaceuticals Ltd

time outline iconNew Delhi, Delhi, India

Posted on 28-09-2023

652 Views

1 Vacancy

Description

  • Follow up from plant R&D Team for AMD, AMV, Tech Transfer, Stability Charging Date, AMV timeline
  • Follow up with Purchase Department for API Documents and review of API Documents of vendor
  • Dossier Compilation & Review of both Finished Product and API
  • Preparation of all technical document of dossier like package insert, rationale, drug-drug interaction.
  • Review of artwork for DCGI
  • Prepare all modules (Module 1,2,3,4 & 5) and submit to CDSCO
  • Prepare Dossier for IPC Submission and reply of Subsequent Queries Independently
  • CT-16 application for import of new API and new RLDs
  • CT-10, 12 & 12 application(Form-29)

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Preferred Education

BPharm (Bachelor Of Pharmacy)

Key Skills

Attention to DetailCommunicationProblem Solving SkillsDRA OfficerWork Ethic

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