Basic understanding of FDA and local laws/authorities, Knowledge of drug and finished product regulations, Preferred qualification as a pharmacist, Open to freshers or candidates with 0-2 years of experience..
Key responsibilities:
Perform administrative functions related to regulatory affairs
Assist in compliance with FDA and local regulations
Support the preparation of documentation for drug products
Collaborate with team members on regulatory submissions.
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Genedrift has been a trusted Regulatory and Pharmacovigilance provider across the entire business value chain. Whether pre or post market approved product safety, complaints management, medical inquiry support and post market surveillance through submission. Your organization's business requirements are unique and we excel at developing customized solutions leveraging our experience and team to automate and streamline business processes, aligning to our clients strategic objectives and providing a business solution that seamlessly integrates as a part of your organization, leading to customer satisfaction.