CW-Regulatory Affairs Associate/Senior Associate

Amgen · Hong Kong

Career Category

Corporate Services

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