CW-Regulatory Affairs Associate/Senior Associate
Amgen · China
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Regulatory Affairs Associate or Senior Associate in Hong Kong to coordinate and execute regulatory submissions in compliance with corporate and local requirements. The role involves managing documentation, preparing labeling materials, and partnering with regional teams on drug registration and lifecycle management.
What they're looking for
- Bachelor's degree in scientific or related field
- Knowledge of regulatory principles and drug development processes
- Experience working with policies, procedures, and standard operating procedures
- Ability to understand and communicate scientific and clinical information
- Demonstrated capability to work effectively in cross-functional teams
What you'll be doing
- Ensure regulatory submissions meet timelines and corporate/local regulatory standards
- Create and review source text for country-specific labeling materials
- Review promotional and non-promotional materials for regulatory compliance
- Coordinate translations and exchanges of regulatory information with colleagues and teams
- Partner with Regional Regulatory Leads to support drug registration and lifecycle management
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.