RAD-Canada Market
6 days ago
Required 4 - 5yrs regulatory experience candidate with specialization in M Pharm (Pharmaceutics)
Job Description
- Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module
- Well versed with Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations during review cycle)
- Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development) for effective review of R&D documents.
- Should be aware of post approval variation requirements. Should have basic QA knowledge to enable correct review of plant related documents
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