Sr Associate Regulatory Affairs - CMC (x2)
Amgen(2 months ago)
About this role
A Senior Associate Regulatory Affairs – CMC at Amgen supports product development and global registration by developing and executing regulatory CMC strategies across the product lifecycle. The role sits on the ROOTS2 team and interfaces with global, site, biosimilars RA CMC teams and device teams to support CMC submissions and lead product-support projects.
Required Skills
- Regulatory CMC
- Project Management
- Document Management
- Submission Preparation
- Quality Assurance
- Process Development
- Analytical Development
- Stakeholder Management
- Training
Qualifications
- Bachelor's Degree
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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