Quality and Regulatory Affairs Specialist

Essex Bio-Technology (EssexBio) is a bio-pharmaceutical company. Our portfolio of products aims to deliver solutions to commercial and clinical unmet needs, covering a wide range of therapeutic areas, which include Ophthalmology, Dermatology and Wound Healing. With a growing international presence across the U.S., Europe, and Asia, EssexBio offers employees the opportunity to participate in cross-border projects.

EssexBio is listed on the Hong Kong Stock Exchange with operating headquarters in Singapore and Zhuhai, serving Asia-Pacific and China respectively. In Singapore, EssexBio through its subsidiaries is focused on translational research, healthcare services and market access for biopharmaceutical products.

This job posting is for a role at our operating headquarters in Singapore (through one of our subsidiaries), offering the chance to contribute to EssexBio's regional and global operations, strengthening our overall regional impact and innovation in healthcare.

About The Role

We are seeking a Quality and Regulatory Affairs (QRA) Specialist to support quality and regulatory activities for our products. In this role, you will ensure full QMS, oversee product quality processes, and supporting the full lifecycle management of products within our group.

This position offers potential regional exposure and the opportunity to build a progressive career in the QRA industry.

Key Responsibilities

Quality Assurance (QA)

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

Regulatory Affairs (RA) / Pharmacovigilance (PV)

1. Lead and/ or manage drug safety detection activities.
2. Coordinate and deliver internal training to ensure regulatory and quality compliance.

Others

1. Manage and maintain all documents and records related to QRA, ensure regulatory compliance.
2. Participate in the preparation of premarket regulatory submissions for commercial distribution.
3. Ensure accurate records of training, roles and systems used in GxP functions.
4. Support ad-hoc tasks and cross-functional initiatives when necessary.

Requirements

• Degree in Engineering, Life Sciences, Pharmacy, or a related discipline.
• Strong documentation, problem-solving, and communication skills.
• Exposure to Quality & Regulatory Affairs (QRA) activities, including QMS, SOP development, and inspection readiness.
• Familiarity with GDPMDS, GDP, regulatory inspections, and compliance is an advantage.
• 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.