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