Compliance

• Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission)
• Act as the point of contact with regulatory agencies
• Provide guidance on local mechanisms to optimize product development and regulatory approvals
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements
• Ensure and support local regulatory product compliance (eg, agency commitments)
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures
• Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc.
• Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions
• Provide primary authorship to routine regulatory correspondence

US Regulatory Lead

Compliance Consultant, GDP – Contract

Compliance Intern

Lead, Oncology – Global Regulatory Policy & Innovation

Compliance Manager – E&S Insurance

Compliance Analyst II