Key Responsibilities:

• Regulatory Submissions & Approvals
• Prepare, compile, and submit product registration dossiers to HSA and other relevant regulatory authorities.
• Maintain up-to-date knowledge of Singapore’s Health Sciences Authority (HSA) guidelines, ASEAN Common Technical Dossier (ACTD), and other regional requirements.
• Ensure timely approvals for new product launches, renewals, and variations.
• Compliance & Documentation
• Review product artwork, labels, and promotional materials for compliance with regulatory standards.
• Maintain regulatory databases and ensure that product licenses, certificates, and approvals are current.
• Support internal audits and regulatory inspections (e.g., HSA GMP audits).
• Cross-Department Collaboration
• Work closely with Quality Assurance, R&D, and Production to ensure regulatory compliance throughout the product lifecycle.
• Provide regulatory guidance for new product development and market expansion projects.

Regulatory Intelligence:

• Monitor regulatory changes in Singapore and ASEAN markets and communicate impacts to management.
• Support the development of strategies to address new regulations or compliance risks.