Regulatory Affairs Senior Manager (CMC)

The RA CMC Senior Manager is responsible for execution and/or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products.

Requirements

• Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products.
• Provides strategic regulatory input and regulatory risk assessments for product teams;
• Executes regulatory strategy with respect to preparation of submissions;
• Complies with critical RA CMC processes;
• Identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance;
• Reports needs for process changes to CMC systems and contributes to process improvements;
• Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams;
• Reports issues to RA CMC product team management;

Benefits

• Competitive benefits
• Collaborative culture