Jobs in Beijing | Shanghai | Tianjin | Nanjing | Suzhou | Hangzhou | Guangzhou | Shenzhen | Dongguan | Dalian | Qingdao | Chongqing | Harbin

Head of Clinical Quality Assurance & Regulatory Affairs

Additional Information

  • Post Title: Head of Clinical Quality Assurance & Regulatory Affairs
  • category: Manufacturing & Industrial
  • subcategory: Quality Assurance jobs
  • No. of Vacancies: 1
  • Location: Beijing
  • Posting duration: 2019/6/1 ~ 2020/9/1
  • Level of Spoken Chinese: Fluent
  • Nationality: all
  • Education: bachelor
  • Work Experience: One Year
  • Gender: F/M
  • Age:
  • Work Status: Fulltime
  • Salary: negotiate
  • Position responsibilities and other requirements:
Develop regulatory affairs and quality assurance team and
provide team leadership;
Define and implement the regulatory strategy for new
products introduction;
Obtain administrative authorization from the local health
authorities to put the drug on the market;
Maintain all regulatory files for new products in accordance
with health authorities requirements and timelines;
Maintain all regulatory files for product renewal and line
extensions in accordance with health authorities requirements and timelines;
Validate promotional communication materials in line with
health authority requirements and legislations;
Keep good relationship with local health authorities;
Provide advice and advance warning on potential regulatory
risks and propose preventive or corrective measures accordingly;
Put forward a pharmaco-economic strategy to obtain the best
pricing of the product;
Assist in the resolution of GCP, GLP and GMP issues;
Provide guidance and training to management and staff
regarding clinical trials and the implementation of GCP, GLP and GMP in
collaboration with the quality assurance / quality control unit.


Other Jobs

Job searchAdvanced