Support new product and technology transfer activities. Review and approve tech transfer documentation. Coordinate with Production, QC, R&D, and Regulatory teams.
Maps potential of territory bringing in insights from market trends, referral pathway bottlenecks, competitors’ activities and unmet needs from a patient and care-giver perspective.
Green Field Project -Equipment Qualification & Computer System Validation, HVAC, Water System, Compressed Air, Nitrogen system Qualification & Temperature Mapping.
Perform analysis of ointment, cream, gel, solution, raw material, and stability samples. Hands-on experience with HPLC, UPLC, GC, UV, IR, pH, viscosity, and assay testing.
This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.