Global QA & Regulatory Affairs Specialist

Essex Bio-Technology; Singapore; On-site; SGD 65,000 - 95,000; Full time

Job summary

Essex Bio-Technology in Singapore seeks a Quality and Regulatory Affairs (QRA) Specialist to support quality and regulatory activities across products, ensuring full QMS, product quality processes, and lifecycle management.

You will lead QA and RA tasks, assist in inspections, prepare regulatory submissions, train staff, and maintain documents, with regional exposure and opportunities for career growth within a fast-growing biotech group.

Qualifications

• Degree in Engineering, Life Sciences, Pharmacy, or related field.
• Strong documentation, problem-solving, and communication skills.
• Exposure to QMS, SOPs, and inspection readiness.
• Familiarity with GDPMDS, GDP, regulatory inspections, and compliance is a plus.
• Experience in regional QRA roles, SME distribution companies, or start-up / fast-growing environments is a plus.
• Non-pharmacists with relevant experience in QA, compliance, or pharmaceutical distribution are welcome.
• Fresh graduates with a pharmacist licence who are keen to build a career in the pharmaceutical industry are encouraged to apply.

Responsibilities

• Assist in implementing and maintaining the company’s Quality Management System (QMS).
• Handle and manage QRA-related inspections.
• Maintain QRA-related licences and compliance.
• Manage new and existing supplier management activities.
• Manage investigations for deviation, non-conformity, CAPA and complaints.
• Review technical documentation and perform basic investigation.

Skills

Quality Assurance

Regulatory Affairs

Documentation

Communication

Inspection readiness

GxP

Education

Engineering degree

Life Sciences degree

Pharmacy degree

Job description

Essex Bio-Technology in Singapore seeks a Quality and Regulatory Affairs (QRA) Specialist to support quality and regulatory activities across products, ensuring full QMS, product quality processes, and lifecycle management.

You will lead QA and RA tasks, assist in inspections, prepare regulatory submissions, train staff, and maintain documents, with regional exposure and opportunities for career growth within a fast-growing biotech group.