Senior Associate Regulatory Affairs - Clinical Studies (CDMX)
Amgen(22 days ago)
About this role
Amgen is seeking a Senior Associate Regulatory Affairs for Clinical Studies in Mexico who provides high-level regulatory leadership to ensure compliance and successful execution of clinical trial authorizations. The role involves strategic collaboration with global and local teams, managing regulatory documentation, and maintaining inspection readiness, within a pioneering biotech environment dedicated to serving patients with serious illnesses.
Required Skills
- Regulatory Affairs
- GCP
- DIGIPRiS
- COFEPRIS
- Clinical Studies
- Regulatory Strategy
- Documentation
- Inspection Readiness
- Ethics Committees
- Regulatory Submission
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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