DRA Officer
0 - 2 Years of ExperienceNot disclosed Full Time
Akums Drugs and Pharmaceuticals Ltd
New Delhi, Delhi, India
Posted on 28-09-2023
646 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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