- Hong Kong Hong Kong
全职 Regulatory Affairs Specialist 工作, 薪水, Career International AP (Hong Kong) Limited Hong Kong 公司招聘中 - Ricebowl
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职位描述
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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.
Temporary,Contract
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.
Temporary,Contract
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