Senior Research Associate / Research Associate / Senior Research Assistant (Regulatory Affairs) (PR0041/21-22)

Job level Middle
Education Bachelor Degree
Location
Shatin
Industry Education / Training
Job function Education / Training > Others
Medical Services > Specialist
Science / Lab / Research > Laboratory
Published On 22/07/2021
ref. PR0041/21-22

SCHOOL OF CHINESE MEDICINE

Applications are invited for the following post in the Centre for Chinese Herbal Medicine Drug Development, which is located in the Hong Kong Science Park.

Centre for Chinese Herbal Medicine Drug Development
Senior Research Associate / Research Associate / Senior

Research Assistant (Regulatory Affairs) (PR0041/21-22)

The appointee will participate in research projects relating to cutting-edge new drug development with Chinese herbal medicine, and be responsible for formulation and implementation of strategic plans and document preparation for the investigational new drug (IND) application from China, Japan, Europe as well as United States.

Duties:

  • Participate in the preparation, compilation and submission of regulatory dossiers to gain clearances/approvals for Mainland China, including HK, US, Japan and EU;
  • Review technical plans and reports to ensure data accuracy, traceability and compliance to standards;
  • Review new regulations or guidance documents and assessing their impact on the assigned projects;
  • Communicate with health authorities or contract research organisation (CRO) to facilitate regulatory clearances and approvals;
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies;
  • Collaborate with cross-functional teams to identify, prioritise, and oversee the execution of good clinical practice (GCP), good laboratory practice (GLP), and good manufacturing practice (GMP) processes;
  • Collaborate with support functions for developing and implementing inspection readiness plans;
  • Assist in routine audit conducted by external consultants; and
  • Undertake any other duties as assigned.

 

Requirements:

  • A bachelor’s degree in health-related science, medicine, pharmacy, biological science or any other medical related field;
  • Applicants with a higher level of qualification and/or more experience will be considered for the post of Senior Research Associate or Research Associate;
  • Experience in regulatory affairs/quality control from pharmaceutical or biotechnology industry with in-depth knowledge and understanding of the regulatory environment worldwide;
  • Competency in new drug application and registration locally and globally, such as China’s National Medical Products Administration, the United States Food and Drug Administration, etc;
  • Knowledge of drug research and development will be advantageous;
  • An excellent command of written and spoken English and Chinese (Cantonese and Putonghua);
  • Effective communication and interpersonal skills, including the ability to interact with all levels of the Centre; and
  • Diligent, exhibits integrity and commitment to high ethical and compliance standards.

 

Initial appointment will be offered on a fixed-term contract of two years. Re-appointment thereafter will be subject to mutual agreement and availability of funding.

Shortlisted candidates will be invited to attend a written assessment.
Rank and salary will be commensurate with qualifications and experience.

Application Procedure:
Applicants are invited to submit their applications at the HKBU e-Recruitment System (jobs.hkbu.edu.hk). Those not invited for interview 8 weeks after submission of application may consider their applications unsuccessful. Details of the University’s Personal Information Collection Statement can be found at http://hro.hkbu.edu.hk/pics.

The University reserves the right not to make an appointment for the post advertised, and the appointment will be made according to the terms and conditions then applicable at the time of offer

Closing date: 7 August 2021