Executive Regulatory Affairs (Healthcare)

1. Regulatory registration and product lifecycle management
• Lead the preparation, review, submission, and maintenance of product registration dossiers in compliance with applicable regulations.
• Develop and execute regulatory strategies for new product registrations, renewals, variations, and post-approval changes.
• Monitor registration timelines and ensure timely approvals from Health Authorities.
• Coordinate responses to regulatory inquiries and deficiency letters to facilitate product approvals.
• Ensure continuous compliance and maintenance of all product licenses and registrations.
2. Handle promotional materials:
• Review and approve promotional materials, product advertisements, drug information, and symposium content to ensure compliance with applicable regulations and company policies.
• Provide regulatory guidance to relevant teams on promotional activities.
• Ensure promotional claims are accurate, scientifically supported, and aligned with approved product information.
3. Regulatory consulting
• Provide regulatory advice and guidance to clients and internal departments regarding local regulatory requirements and compliance obligations.
• Monitor changes in regulations, guidelines, and industry requirements.
• Assess regulatory impacts on existing products and business operations and provide proactive recommendations.
4. Cross-functional collaboration
• Work closely with Supply Chain, Quality Assurance, Medical Affairs, Commercial, Tender and other departments to ensure smooth product importation, distribution, and commercialization.
5. Compliance and reporting
• Ensure regulatory compliance across all products and activities.
• Prepare the performance reports to senior management/ clients
• Support inspections, audits, and regulatory compliance activities.
• Maintain accurate and complete regulatory documentation and records.
6. Other responsibilities
• Support other tasks assigned by RA management