高級註冊藥劑師的主要職責為 —
(a) 推動香港藥物及醫療器械監督管理中心(下稱“藥械監管中心”)籌備辦公室的工作，加快藥械監管中心正式成立；
(b) 為設立第一層藥物審批框架／架構進行籌備工作，例如就執行計劃提供意見、評估“國際醫藥法規協調會議”(下稱“ICH”)的規定，以及協助制訂／推行第一層審批框架；
(c) 研究本港與海外的藥物監管制度／組織架構／法律框架並將兩者作一比較，從而制訂日後適用於本港的管治及指揮架構；
(d) 監管ICH會員申請所需的所有準備工作，以及本地製藥業推行ICH指引的情況；
(e) 為藥械監管中心擬備建議書，以便中心執行統合監管職能；
(f) 檢討現行的藥物法例，並提出適當的修訂建議；
(g) 率領一隊專業人員研究並檢討有關中醫藥規管的指引及標準，例如《臨牀試驗質量管理規範》、《生產質量管理規範》、《中成藥註冊申請手冊》等；
(h) 負責就(g)項的指引及標準向香港中醫藥管理委員會提供建議；
(i) 負責就(g)項的經修訂指引及標準與本地持份者聯繫溝通，並規劃相關實施安排；
(j) 就經修訂指引及標準的相關事宜，統籌本港與內地和國際機構／組織之間的合作事宜；以及
(k) 執行上司指派的任何其他職務。

(備註：可能須要執行隨時候召職務或在正常辦公時間以外工作。)

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.)