AbbVie Regulatory Affairs Associate in Beijing, China

Description:

  • Contribute to draft regulatory timelines, timely make recommendations to adjust the action plan to manager
  • Perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with regulations, guidelines and internal processes
  • Work with JAPAC regulatory contact to prepare and review registration dossier to ensure scientific rigor, accuracy, and clarity
  • Compile submission packages and ensure timely submission upon internal review and approval
  • Prepare response docuemnts as requested by regulatory authorities
  • Monitor regualatory authorities’ review and approval processes, keep manager advised of the progress, and discuss critical issues and potential solutions before implementation
  • Handle QC validation testing, resolve technical issues to ensure timely completion
  • Design and modify Chinese artworks for package insert, pack and label, in line with relevant regulatory requirements
  • Review promotional and educational materials to ensure compliance
  • Collect information on competitive products, provide regulatory supports and advices to other personnel in China affiliate
  • Maintain all regulatory documentation
  • Assist manager to complete urgent assignment as requested in a time manner

Qualifications:

  • years regulatory affairs experiences in pharmaceutical or biotech industry
  • Working experience with multinational company
  • Experience with clinical trial application and/or new drug applications
  • Familiar with regulatory guidelines and requirements
  • Good wr itten and oral communication skills in both English and Chinese
  • High scenes of work quality, looking into details
  • Good communication skill, team work
  • Fast learning capability

Job Classification: Experienced
Job: REGULATORY AFFAIRS
Primary Location: China-Beijing-Beijing
Organization: Research & Development
Schedule: Full-time
Shift: Not required
Travel: Yes, 10 % of the Time
Req ID: 1704143