Senior Regulatory Affairs Manager -PRC Market (station in PRC)

Senior Regulatory Affairs Manager -PRC Market (station in PRC)

Our client is newly established biotechnology firm which spinout from The Chinese University of Hong Kong. It is  founded by world renowned clinician scientists. She is now inviting calibre candidate to join her team with the requirements below:

RESPONSIBILITIES:

  • Develop and implement the new product NMPA registration strategies in China
  • Handle NMPA Registration of new products in the category of IVD and health supplement
  • Manage Regulation affairs of China site, include new products launch, changes and renewal registration
  • Liaise with R&D for document preparation and submission
  • Responsible for CRO vendor selection and management
  • Uses knowledge and experience in the regulatory field to influence functional objectives.
  • Monitor the Product compliance of post marketing.
  • Handle OEM manufacturer quality management in liaison with commercial sector

 REQUIREMENTS:

  • Over 10 years of proven track record in regulatory affairs in China, preferably in IVD
  • Science degree in Biotechnology or related field
  • Experienced in managing CRO vendors
  • Excellent in communication, analytical, & project management skills
  • Willing to station in PRC

*** Pls send CV to canwie.chan@levin.hk or contact us at 2520 0064 for more infor.

Negotiable

10 years or above relevant experience

Degree holder or above in Science

PRC


Enquiry: (852) 2520 0064

To apply for this job, please send your CV to canwie.chan@levin.hk


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