CW-Regulatory Affairs Associate/Senior Associate
- Company: Amgen
- Location: China - Hong Kong
- Work mode: On-site
- Job type: Full-Time
- Posted: 2026-10-05
CAREER CATEGORY
Corporate Services
JOB DESCRIPTION
Job Summary
* Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.
* Execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.
* Coordination and execution of Regulatory Affairs processes and deliverables in the local office.
Responsibility:
* Ensures regulatory submissions are made on time and meet company’s corporate and local regulatory requirements.
* Creates and reviews source text for country labeling.
* Reviews promotional and non-promotional materials.
* Coordinates translation for local Regulatory submission,
* Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an 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
.