Job Description
Oversee documentation efforts of our products to ensure compliance with Singapore and International regulations and standards. Monitor emerging trends regarding industry regulations to determine potential impacts on organisational processes.
Understand requirements and timelines for regulatory approvals for specific countries including 1. China NMPA regulatory approval 2. Asia Pacific Region 3. US FDA and to work with Third Party Regulatory compliance companies to ensure success of local registration and regulatory approvals.
Develop regulatory strategies and implementation plans for the preparation and submission of new products. Train staff in regulatory policies or procedures. Coordinate internal discoveries and depositions with relevant staff.
Maintain current knowledge of relevant regulations, including proposed and final rules. Manage activities such as audits, regulatory agency inspections, or product recalls. Partici...
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