Sr Associate Regulatory Affairs

**Job Summary**

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Act as the point of contact with regulatory agencies.
• Plan and manage clinical trial applications through CRO and liaise/coordinate CTA response to queries between CRO and Amgen.
• Manage CRO work invoice and participate in global network.
• Work as a point of contact and oversight for Global Regulatory Affairs & Strategy (GRAAS) between the i...

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