Amgen: Global Regulatory Affairs

Global Regulatory Affairs (GRA) is responsible for the planning and execution of regulatory strategies for the advancement and approval of our products. GRA colleagues develop strategies that leverage innovative clinical trial designs and expedited approval pathways to efficiently deliver our products to patients. US Regulatory Strategy Fellows are embedded in GRA project teams and directly contribute to the development of our products. 

Amgen's product portfolio spans a broad range of therapeutic areas. We focus on six therapeutic areas: 

1. Cardiovascular disease 

2. Oncology

3. Bone health

4. Neuroscience 

5. Nephrology 

6. Inflammation

US Regulatory Strategy Fellows participate in a structured development program which is designed to prepare them for a rewarding career in regulatory affairs. Fellows are assigned to project teams and work with a designated preceptor and under the mentorship of experienced regulatory professionals. 

During their time in the program, they gain a deeper understanding of practical considerations of drug development such as navigating a matrix team environment, addressing discordant feedback from multiple regulatory authorities, and negotiating with the FDA. 

In addition, Fellows are exposed to European Union, Japan, and China regulatory considerations through regular participation in Global Regulatory Teams.