Regulatory Affairs Executive Job in Dynasty clinic

Regulatory Affairs Executive

Dubai, DU, AE, United Arab Emirates

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Job Description

Key Responsibilities:

Prepare, compile, and submit regulatory documents (e.g., IND, NDA, ANDA, BLA, DMF, CE Mark, 510(k), etc.) in compliance with applicable regulations. Monitor and interpret regulatory requirements and communicate relevant changes to internal stakeholders. Ensure timely product registrations, renewals, and amendments with local and global health authorities. Review product labeling, advertising, and promotional materials to ensure regulatory compliance. Liaise with regulatory bodies such as FDA, EMA, MHRA, TGA, SFDA, or local MOHs as necessary. Participate in cross-functional project teams, providing regulatory guidance to R&D, Quality Assurance, Marketing, and Manufacturing. Maintain regulatory files and databases to ensure audit readiness and documentation integrity. Provide regulatory support during inspections, audits, and product recalls as necessary. Track and manage timelines for regulatory deliverables to meet project and launch goals.
Job Type: Full-time

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