Materials Compliance Lead - MAC & Regulatory

Amgen Inc.; Oregon; Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Total Rewards Plan

Flexible work models

Job summary

Amgen seeks a Materials Compliance Manager to oversee MAC review processes and ensure only compliant messages are communicated publicly. You will manage MAC across business units, collaborate with Sponsors and Reviewers, and uphold neutrality while aligning with regulatory requirements.

The role reports to the Director/ED of Material Compliance in Regulatory Affairs, driving process enhancements, stakeholder training, and effective issue escalation to senior management as needed.

Qualifications

• Doctorate degree.
• Master’s degree with 2 years of experience in process, compliance, and/or project management.
• Bachelor’s degree with 4 years of experience in process, compliance, and/or project management.
• Associate’s degree with 8 years of experience in process, compliance and/or project management.
• High school diploma / GED with 10 years of experience in process, compliance and/or project management.

Responsibilities

• Leads MAC process improvement efforts.
• Provides guidance and direction to MAC cross functional team members.
• Anticipates process issues and provides solutions for special circumstance reviews due to product launches and regulatory actions (i.e., label changes, fair balance statements).
• Translates BU/product priorities into material approval strategies in support of business objectives.
• Enforces MAC business rules with Reviewers and Sponsors (project owners).
• Works closely with assigned Material Compliance Associates on MAC operations.
• Builds and maintains relationships with Sponsors, Reviewers, agencies, third party partners, and Business Unit Compliance Lead.
• Drives compliance with MAC guidelines, MAC Policy, and external regulations.
• Facilitates MAC related meetings.
• Addresses stakeholder concerns and facilitates final decisions on resolutions.
• Provides guidance on the use of MAC electronic approval system.

Skills

Negotiation

Collaboration

Analytical judgment

Leadership

Education

Doctorate degree

Master's degree and 2 years experience

Bachelor's degree and 4 years experience

Associate's degree and 8 years experience

High school diploma / GED and 10 years experience

Job description

Amgen seeks a Materials Compliance Manager to oversee MAC review processes and ensure only compliant messages are communicated publicly. You will manage MAC across business units, collaborate with Sponsors and Reviewers, and uphold neutrality while aligning with regulatory requirements.

The role reports to the Director/ED of Material Compliance in Regulatory Affairs, driving process enhancements, stakeholder training, and effective issue escalation to senior management as needed.