Senior/ Regulatory Specialist, Audit Branch
Core
Lead regulatory inspections and licensing for health product manufacturers and dealers in Singapore to ensure quality, safety, and efficacy standards.
Role type
Senior Regulatory Specialist (Audit Branch)
Builds
Regulatory compliance for health product supply chain
Domain
Healthcare regulation / Pharmaceutical quality assurance
Deliverable
client delivery
Required skills
GMP inspection, GDP compliance, regulatory policy review, technical standards development, QMS implementation, stakeholder management, system change assessment, inspection scheduling, international liaison
Preferred skills
Sterile manufacturing experience, aseptic processing knowledge, biopharmaceutical regulatory landscape expertise, additional languages
Technologies
Electronic processing systems, word and data processing applications
Responsibilities
Conduct local/overseas regulatory inspections and licensing, review regulatory policies and legislations, develop technical standards and industry guidelines, implement Quality Management System (QMS), manage stakeholder enquiries, assess changes to electronic processing systems, monitor inspection performance indicators, facilitate international technical liaison
Seniority
Senior, hands-on IC