Sr. Manager Global CMC Regulatory Affairs

Amgen • Washington, DC

278d • Remote

About The Position

The Global CMC Regulatory Affairs 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. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. 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.

Requirements

• Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development.
• Master's degree and 4 years of experience in regulatory or pharmaceutical drug development.
• Bachelor's degree and 6 years of experience in regulatory or pharmaceutical drug development.
• Associate's degree and 10 years of experience in regulatory or pharmaceutical drug development.
• High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development.

Responsibilities

• Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development.
• Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally.
• Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation.
• Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff.
• Develops CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments.
• Develops response strategy and responds to health authority questions.
• Liaises with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans.
• Liaises with local regulatory teams to align on filing strategy.
• Monitors and, as necessary, provides data to be entered into tracking systems for department deliverables and ensures information is current.
• Maintains submission information according to the Regulatory Information Management (RIM) system.
• Follows established department regulatory processes to ensure cross-product alignment.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans and bi-annual company-wide shutdowns.
• Flexible work models, including remote work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree