Regulatory Operation Manager (including Writing Role)

Amgen Inc.

3.6

(9)

Beijing, China

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-184417

    Position summary

    May participate in departmental and cross-departmental initiatives, as appropriate

    • Generate document timelines, with team input

    • Keep abreast of relevant professional information and technology.

    Filing and submission:

    • Lead submission in partnership with TA team

    • Coordinate and follow the dossier package preparation with CMC team and cross-functions

    • Analyze the gaps and needs for China RA in early phase submission

    • Arrange dossier package printing and binding to ensure the submission on time

    • Control the package filing strategy to facilitate simultaneous filing

    • Be responsible for managing the archiving dossiers, certificates and approval letters

    Knowledge and Skills

    • Excellent written/oral communication skills and attention to detail in both English and Chinese

    • Proficiency with word processing and other Microsoft Office Programs

    • Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds

    • Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment

    • Ability to understand and follow complex standard operating procedures (SOP's), guidance documents, and work instructions

    • Proficient time and project management skills

    • Self-starter with a drive and perseverance to achieve results

    • Local regulatory regulation knowledge

    • Good team player

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging