Senior Adviser

A Senior Adviser is mainly deployed on – (a)providing professional advice on the design and implementation of the registration system for pharmaceutical products under the primary evaluation approach; (b)designing and delivering structured mentorship programs to build the technical competence of officers in Drug Office; (c)developing and maintaining technical standards and regulatory guidance for the registration of innovative medical products, ensuring alignment with international benchmarks; (d)leading critical appraisal of clinical data for registration and clinical trial applications, conducting comprehensive benefit-risk assessments, preparing assessment reports, and formulating lifecycle safety surveillance and pharmacovigilance strategies; and/ or providing expert leadership in the scientific evaluation of CMC components for biological products and ATPs, ensuring compliance with established international regulatory standards; and (e)performing any other duties as assigned by seniors. (Remark: May be required to perform on-call duties or work outside normal office hours.)

Candidates should – (a)have a Doctoral Degree in related subjects [Note (1)] from a university in Hong Kong or an equivalent degree from a university outside Hong Kong with at least ten years’ relevant post-graduate experience, including at least five years’ experience in one or more medical products regulatory authorities conducting assessment of pharmaceutical products for clinical trial authorisation or marketing authorisation [Note (2)]; OR (b)have a Master's Degree in related subjects [Note (1)] from a university in Hong Kong or an equivalent degree from a university outside Hong Kong with at least 15 years’ relevant post-graduate experience, including at least five years’ experience in one or more medical products regulatory authorities conducting assessment of pharmaceutical products for clinical trial authorisation or marketing authorisation [Note (2)]; AND (c)have good command of both written and spoken English. Candidates possessing the following will be an advantage – (i)working experience in World Health Organization (WHO) stringent authority or WHO-listed authority; (ii)with medical degree and experience in conducting clinical benefit-risk assessments and formulating policies for safety surveillance, pharmacovigilance, and risk mitigation strategies across the product lifecycle; (iii)experience in conducting technical evaluation of Chemistry, Manufacturing, and Controls (CMC) dossiers for pharmaceutical products, highly preferably with experience on the evaluation of CMC of biological products and Advanced Therapy Products (ATPs); (iv)experience in developing regulatory guidelines or procedures aligned with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards; or (v)participation in regulatory forums, scientific advisory committees, or international technical working groups, including but not limited to ICH or WHO; or (vi)good command of written and/or spoken Chinese (Cantonese and/or Putonghua).