Quality and Regulatory Affairs Specialist

About Essex Bio-Technology

Essex Bio-Technology is a bio-pharmaceutical company specializing in addressing commercial and clinical needs across diverse therapeutic segments such as Ophthalmology, Dermatology, and Wound Healing. With expanding operations internationally in the U.S., Europe, and Asia, the company provides staff opportunities to engage in multinational projects. It is publicly traded on the Hong Kong Stock Exchange, with principal offices in Singapore and Zhuhai serving the Asia-Pacific region and China respectively. The Singapore subsidiary focuses on translational research, healthcare services, and facilitating market access for biopharmaceutical products.

Role Overview

The Quality and Regulatory Affairs (QRA) Specialist position is based at EssexBio's operational head office in Singapore. The role involves supporting and managing activities associated with product quality and regulatory compliance throughout the product lifecycle within the group. This position offers prospects for regional involvement and career growth within the QRA sector.

Key Responsibilities

• Assist with the development, implementation, and maintenance of the company's Quality Management System (QMS).
• Handle QRA inspections and ensure all related licenses and compliances are current.
• Oversee supplier management for new and ongoing partnerships.
• Manage investigations related to deviations, non-conformities, Corrective and Preventive Actions (CAPA), and complaints.
• Review technical documentation and conduct preliminary investigations as needed.
• Lead or coordinate drug safety monitoring and pharmacovigilance activities.
• Organize and conduct internal training to uphold regulatory and quality standards.
• Maintain comprehensive documentation and records for QRA to ensure regulatory adherence.
• Assist in preparation of regulatory submissions for product marketing approval.
• Keep accurate logs of training, roles, and GxP-related systems.
• Support miscellaneous tasks and participate in cross-functional projects when required.

Qualifications and Requirements

• A degree in Engineering, Life Sciences, Pharmacy, or equivalent disciplines.
• Excellent skills in documentation, problem solving, and communication.
• Hands-on experience or exposure to Quality & Regulatory Affairs functions including QMS implementation, SOP formulation, and readiness for inspections.
• Knowledge of Good Distribution Practice for Medical Devices (GDPMDS), Good Distribution Practice (GDP), regulatory inspections, and compliance procedures is advantageous.
• Experience within regional QRA roles, subject matter expertise in distribution, or in start-up and rapidly expanding company environments is beneficial.
• Non-pharmacists with relevant QA, compliance, or pharmaceutical distribution background are invited to apply.
• Recent graduates holding a pharmacist license and interested in pursuing a pharmaceutical career are encouraged to apply.