Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist provides administrative and technical support to the Regulatory Affairs team, ensuring timely preparation, submission, and maintenance of product registrations and post‑approval activities in Hong Kong. The role involves coordinating documentation with manufacturers and guaranteeing compliance with local regulatory requirements.

Key responsibilities

• Prepare, compile and submit product registration dossiers to the Hong Kong Department of Health, coordinating with internal teams and external partners.
• Maintain regulatory databases, submission trackers and archives; prepare standard templates and ensure proper filing of correspondence and approvals.
• Support product lifecycle activities such as variations, renewals, labeling updates and respond to deficiency letters or information requests.
• Liaise with global manufacturers, distributors and local agents, and collaborate with QA, Supply Chain and Marketing to ensure product compliance.
• Monitor local regulatory developments and assist the RA team in implementing changes to stay compliant with updated guidelines.

Required profile

• Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology or related discipline.
• 1–3 years experience in Regulatory Affairs within the pharmaceutical or healthcare industry.
• Strong understanding of the Hong Kong regulatory framework and documentation requirements.
• Experience with biosimilar submissions is an advantage.
• Excellent organizational, communication and coordination abilities; detail‑oriented and able to manage multiple priorities.
• Proficiency in English; Cantonese preferred, Mandarin an advantage.