Regulatory Affairs

Career International AP (Hong Kong) Limited; Hong Kong Island; On-site; HKD 480,000 - 760,000; Full time

Job summary

Career International AP (Hong Kong) Limited is partnering with a global oncology company headquartered in Switzerland, seeking a hands-on regulatory affairs professional in Hong Kong. The role focuses on submission execution and lifecycle management, requiring strong knowledge of HK regulatory framework and experience with PPB/Drug Office submissions.

You will prepare NDAs, variations, and renewals, coordinate with internal teams, maintain documentation, and support inspections.

Qualifications

• 3–7 years of regulatory affairs experience in pharma or biopharma.
• Strong knowledge of Hong Kong regulatory framework and PPB/Drug Office submissions.
• Hands-on experience with PRS 2.0 for online submissions and certificate management.
• Experience preparing NDAs; familiarity with ICH CTD format.
• Understanding GMP, GCP, GLP and product lifecycle.
• Bachelor's degree or above; advanced degree preferred.

Responsibilities

• Prepare, submit, and track regulatory applications including NDAs and variations.
• Support product registrations and lifecycle management.
• Coordinate submissions with internal teams and Hong Kong authorities (PPB/Drug Office).
• Maintain regulatory documentation and archives per company policy.
• Support inspections and respond to authority deficiency letters.
• Develop and update local regulatory SOPs and monitor HK Health Authorities updates.
• Collaborate cross-functionally to meet regulatory and business objectives.

Skills

Regulatory affairs

HK regulatory framework

PPB/Drug Office submissions

PRS 2.0 online submissions

NDA preparation

ICH CTD familiarity

GMP/GCP/GLP knowledge

English/Cantonese/Mandarin

Education

Bachelor's degree or above

Tools

PRS 2.0

Job description

About the role

We are partnering with a global oncology company headquartered in Switzerland, with commercial operations spanning the US, Europe, and Asia-Pacific. The company has built one of the broadest oncology pipelines in the industry. This is a hands-on regulatory affairs role focused on submission execution and lifecycle management.

Key responsibilities

• Prepare, submit, and track regulatory applications including NDAs, clinical trial applications, import permits, variations, and renewals
• Support product registrations and post-approval lifecycle management activities
• Coordinate submission activities with internal teams and the Pharmacy and Poisons Board (PPB) / Drug Office
• Maintain regulatory documentation, submission records, and archives in line with company policies and local requirements
• Support regulatory inspections, Health Authority requests, and deficiency letter responses
• Develop and maintain local regulatory SOPs and monitor updates from Hong Kong Health Authorities
• Collaborate cross-functionally to support regulatory and business objectives

About you

• 3-7 years of regulatory affairs experience in the pharmaceutical or biopharmaceutical industry.
• Solid, hands-on knowledge of Hong Kong's regulatory framework — direct experience with PPB / Drug Office submissions is essential, including familiarity with the "1+" registration mechanism.
• Practical experience operating Hong Kong's Pharmaceuticals Registration System (PRS 2.0) for online submission, application tracking, and electronic certificate management.
• Experience preparing NDAs; working knowledge of ICH CTD format.
• Understanding of GMP, GCP, and GLP regulations and the pharmaceutical product lifecycle.
• Background from an MNC pharmaceutical company or CRO based in Hong Kong.
• Fluency in English, Cantonese, and Mandarin (written and spoken).
• Bachelor's degree or above required; advanced degree preferred.

Advantageous

• Experience with Biologics License Applications (BLAs) / biopharmaceutical regulatory submissions.
• Existing local professional network (internal stakeholders, external partners and local health authorities) within the Hong Kong pharmaceutical regulatory community.