CW-Regulatory Affairs Associate/Senior Associate

Amgen Inc.

3.6

(9)

Hong Kong

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-153356

    Position summary

    n ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.

    • Partners with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all company molecules.

    • Partners with peers to ensure consistency on procedures

    • Assists locally in Healthcare Compliance activities, where applicable.

    • Participates in local regulatory process improvements, initiatives and training.

    • Oversees external vendor/contractor relationships, where applicable.

    Requirements:

    • Bachelor's degree in scientific area or related

    • Knowledge of Regulatory principles.

    • Working with policies, procedures and SOP's.

    • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.

    • Understanding of drug development.

    • Demonstrate ability to work in teams.

    • Ability to understand and communicate scientific/clinical information

    .

    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