Quality and Regulatory Affairs Specialist

About the role

Essex Bio-Technology is seeking a Quality and Regulatory Affairs (QRA) Specialist to support the quality and regulatory lifecycle of its biopharmaceutical products. Based at the Singapore operating headquarters, you will work across regional and global teams to ensure compliance and drive continuous improvement.

Key responsibilities

• Implement and maintain the company’s Quality Management System (QMS).
• Manage QRA‑related inspections, licences and compliance activities.
• Oversee supplier management, deviation investigations, CAPA, and complaint handling.
• Review technical documentation and conduct basic investigations.
• Lead drug safety detection activities and support pharmacovigilance processes.
• Coordinate internal training to ensure regulatory and quality compliance.
• Maintain all QRA documentation and records.
• Assist in preparing pre‑market regulatory submissions for commercial distribution.
• Support ad‑hoc cross‑functional projects as needed.

Required profile

• Degree in Engineering, Life Sciences, Pharmacy or a related discipline.
• Strong documentation, problem‑solving and communication abilities.
• Exposure to QRA activities such as QMS, SOP development and inspection readiness.
• Familiarity with GDPMDS, GDP and regulatory inspections is advantageous.
• Experience in regional QRA roles, fast‑growing environments or pharmaceutical distribution is a plus.
• Non‑pharmacists with relevant QA/compliance experience are welcome.
• Fresh graduates with a pharmacist licence eager to build a career in the industry are encouraged to apply.

Required skills

• Quality Management System (QMS)
• GDPMDS
• GDP
• SOP development
• Inspection readiness
• Pharmacovigilance
• Drug safety detection