Regulatory Affair Executive

POLI MEDICAL COMPANY PTE. LTD.; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A healthcare firm in Singapore is seeking a regulatory professional to oversee submissions and approvals to the Health Sciences Authority (HSA). The role involves preparing product registration dossiers, ensuring compliance with regulatory standards, and collaborating with internal departments for product development and market strategies. The ideal candidate should possess strong regulatory knowledge and be adept at monitoring regulatory changes affecting the industry.

Qualifications

• Strong knowledge of regulatory submissions and approvals processes.
• Experience with compliance documentation and maintaining regulatory licenses.
• Ability to monitor and interpret regulatory changes.

Responsibilities

• Prepare and submit product registration dossiers to regulatory authorities.
• Review artwork and promotional materials for compliance.
• Work with cross-functional teams to ensure regulatory compliance.

Job description

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.