Development of In house & Site Transfer products,
Aletrnate source Development, Trouble shooting & Execution of Submission batches,
Formulations & Development
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Key Skills : biotechnologist,clinical research executive,r&d engineer,pharmaceuticals engineer,r&d...
Preparing documents for obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.
-Compilation & review of documents for dossier submissions.
-Addressing queries received on dossiers submitted for approvals.
Submission of Module 2-3 Variation Filing, Responding Regulatory Queries, Literature Clinical Data
*preparation & Registration of Dossiers as per Country Guidelines and Checklist
*review of Product Development Report, Specifications