Job Description
Review & Ensure of all the development documents meeting the regulatory requirements.
Preparation, review and compilation of CTD dossier for Europe, Canada, Australia and Emerging market countries. Query responses to Europe, Canada, Australia and Emerging market countries
Review of registration dossiers
Required Candidate profile
Qualification Qualification- M Pharma/ Msc
Location(s) Bangalore (Prefrably from Bangalore candidates)
Job Classification
Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time
Education
Under Graduation: Any Graduate in Any Specialization
Post Graduation: M.Pharma in Pharmacy, MS/M.Sc(Science) in Any Specialization
Doctorate: Doctorate Not Required
Contact Details:
Company: Medreich Limited
Location(s): Bengaluru
Keyskills:
CTD
compilation
Module 4 & Module 5
review
europe market
regulatory affairs
variation filing
preparation