Amgen Regulatory Operation Manager in Beijing, China
Filing and submission:
Lead submission in partnership with TA team;
Coordinate and follow the dossier package preparation;
Analyze the gaps and needs for China RA in early phase submission;
Arrange dossier package printing and binding to ensure the submission on time;
Control the package filing strategy to facilitate simultaneous filing.
Be responsible for managing the archiving dossiers, certificate and approval letters
Manage all filing plans and identify resource issue to balance workload within local regulatory
Proactively manage and implement new regulatory initiatives and guidelines and administrative procedure
provide expertise support on RA database and other related system. (e.g. EPIC, LEXA, GRIP, RA China Sharepoint, RIM)
Learn well global SOPs on regulations;
Drive and work with RA associates to identify process improvement areas and develop new local working procedure;
Lead annual update of local regulatory working procedure.
Experience on CTA/NDA/variation dossier package preparation and submission;
More than six years in industry;
Be familiar with agency requirements on dossier package Module 1-5
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.