Regulatory Affair Executive

3 weeks ago

Singapur, Singapore POLI MEDICAL COMPANY PTE. LTD. Full time

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. #J-18808-Ljbffr

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