Amgen CW-Regulatory Affairs Associate in Hong Kong, Hong Kong
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.
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.
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
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.