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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