A Registered Senior Pharmacist is mainly deployed on -

• (a)To facilitate the Preparatory Office of the Hong Kong Centre for Medical Products Regulation (“CMPR PO”) in the running up to the formal establishment of CMPR;
• (b)To perform preparatory work for the primary drug evaluation framework / infrastructure, e.g. providing inputs on execution plan, conducting assessment on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) requirements, and assisting in the development / implementation of the primary evaluation framework;
• (c)To study and compare overseas drug regulatory regimes / organisational structure / legal framework, with that of Hong Kong, and formulate a governance and command structure that suits the future need of Hong Kong;
• (d)To oversee all the preparatory work for the ICH Membership application and implementation of ICH guidelines in local pharmaceutical industry;
• (e)To draft proposal for CMPR in performing integrated regulatory functions;
• (f)To review and propose appropriate amendments to current legislation on drugs;
• (g)To lead a team of professional staff to conduct research on and review of guidelines and standards relating to the regulation of Chinese medicine, such as Good Clinical Practice, Good Manufacturing Practice, Registration of Proprietary Chinese Medicines Application Handbook, etc.;
• (h)To be responsible for making recommendations to the Chinese Medicine Council of Hong Kong in relation to the guidelines and standards in (g);
  • (i)To be responsible for engaging and communicating with local stakeholders on the revised guidelines and standards in
• (g)and plan for their implementation;
• (j)To coordinate the collaborations with Mainland and international institutes and organizations on matters relating to the revised guidelines and standards; and
• (k)To perform 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)be registered with the Pharmacy and Poisons Board of Hong Kong established under the Pharmacy and Poisons Ordinance, Chapter 138;
• (b)hold a valid Practising Certificate issued by the Pharmacy and Poisons Board of Hong Kong;
• (c)have at least fifteen years’ relevant post-registration experience (Notes 1-2);
• (d)have good project management skills and communication skills; and
• (e)proficiency in written Chinese and English, and good command of spoken Cantonese, Putonghua and English.

Candidates who have previous working experience in drug regulatory authority or pharmaceutical industry on drug regulatory affairs, health informatics, pharmacovigilance, clinical trials, good manufacturing/distribution practice, and/or candidates who have worked in drug regulatory authorities outside Hong Kong will have an advantage.