Senior/Regulatory Specialist, Audit Branch

About the role

The Audit Branch supports the regulatory inspection and licensing regime covering dealers across health product categories in Singapore, helping ensure health products meet standards of quality, safety and efficacy. This Senior/Regulatory Specialist leads or assists in regulatory inspections and licensing of manufacturers, dealers and pharmacies, and reviews policies, standards and stakeholder enquiries.

Key responsibilities

• Lead or assist in local and overseas regulatory inspections and licensing of manufacturers, dealers and pharmacies against GMP, GDP and other quality system standards.
• Review regulatory policies and legislation and turn them into technical and operational plans.
• Review, develop and implement technical standards, industry guidelines and internal GMP inspection guidance.
• Implement the branch's Quality Management System in line with PIC/S, ISO 9001 and other international standards such as WHO ML4 and WLA.
• Handle stakeholders' technical and procedural enquiries and assess changes to electronic inspection and licensing systems.
• Schedule inspections and monitor performance indicators, and help share inspection knowledge with the Branch Director and Unit Deputy Director.
• Work with international colleagues on technical liaison with other regulatory authorities.

Required profile

• Relevant knowledge in science or technology related to health products (pharmacy, life sciences, pharmacology, chemistry, chemical engineering, biotechnology, microbiology).
• Experience in pharmaceutical or biopharmaceutical manufacturing and/or quality functions; typically 2-5 years or more, though candidates without experience but with relevant scientific qualifications are welcome.
• Good understanding of the international regulatory landscape, especially for biopharmaceuticals, cell, tissue and gene therapy products.
• Passion for GMP inspection and good knowledge of international GMP standards (e.g. PIC/S GMP).
• Willingness to travel for overseas inspections and assignments.
• Ability to work in a multidisciplinary team and proficiency in English; additional languages are an advantage.

Required skills

• Familiarity with computer software, including word and data processing applications.
• Knowledge of international GMP standards (PIC/S GMP).

What we offer

• A 1-year contract with an option for automatic renewal for a further year.