Senior Regulatory Specialist – Licensing & Certification

About the role

This senior position supports the Licensing and Certification Branch in implementing Singapore's regulatory inspection and licensing regime for health product dealers and controlled substances. You will help maintain a robust healthcare regulatory framework while enabling innovation in the pharmaceutical sector.

Key responsibilities

• Conduct regulatory inspections, audits, and licensing oversight of health‑product manufacturers, dealers, and premises to ensure compliance with storage, security, GMP, GDP and other standards.
• Monitor licensed activities, investigate potential contraventions and recommend enforcement actions.
• Maintain detailed licensing records and prepare monthly, quarterly and annual statistical reports for senior management and authorities.
• Evaluate licence applications for controlled drugs, psychotropic and psychoactive substances.
• Develop and review SOPs, workflows and collaborate with internal groups, external agencies and law‑enforcement bodies.
• Contribute to policy development by drafting new guidelines and updating existing regulations.
• Arrange meetings with external parties and communicate regulatory requirements to industry stakeholders.

Required profile

• Relevant knowledge or experience in pharmacy, chemistry, pharmacology or a related scientific discipline.
• At least three years of experience in pharmaceutical regulation, drug control or related regulatory work.
• Familiarity with health‑product legislation, international drug‑control conventions and pharmaceutical manufacturing standards.
• Ability to work independently and as part of a team, with strong analytical and communication skills in English.

Required skills

• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Regulatory inspection and audit
• Licensing oversight
• SOP development and review