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Glenmark Pharmaceuticals Job Opening For M.Pharma/ B.Pharma/ Msc - RA Dept |
Location: Navi Mumbai
Department: Regulatory Affairs
Market: USA
Dosage: Inhalation systems (MDI, DPI)
Role: Assistant Manager
Qualification: M.Pharm, B.Pharm, M.Sc
Experience: 06-09 years
Job Responsibilities:
•Have hands of Experience in data review of dossiers for ANDA Product submission.
• Imapart training to cross functional teams for data requirement and understanding as per current USFDA practices.
•In depth knowledge of DMF parts and understanding of ICH requirements for API and finished Formulation.
• Data requirement from Product Development Report and seek data clarity from Formulation Development and Analytical Research Development teams.
• Knowledge of Analytical Method Validation requirements, and parameters to be include in Specifications, Stability and Photostability.
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