Materials Compliance Lead — Regulatory Affairs

Amgen Inc.; United States; Remote; USD 106,000 - 143,000; Full time

Benefits offered by this job

Retirement plan

Stock incentives

Paid time off

Job summary

Amgen is seeking a Materials Compliance Manager to oversee MAC review and approval to ensure compliant messaging to the public. You will report to the MAC leadership in Regulatory Affairs and coordinate with sponsors, reviewers, and external partners.

You will drive MAC process improvements, manage stakeholder expectations, and ensure adherence to MAC policies and regulatory requirements across assigned business units.

Qualifications

• Doctorate degree required and relevant field.
• Experience in regulatory affairs or material compliance in biopharma.
• Experience with MAC process and cross-functional teams.
• Strong communication and project management skills.
• Ability to manage multiple stakeholders and priorities.

Responsibilities

• Leads MAC process improvement efforts.
• Guides MAC cross-functional team members.
• Addresses issues and provides solutions for special reviews during launches.
• Translates business priorities into MAC strategies to support objectives.
• Enforces MAC rules with Reviewers and Sponsors (project owners).
• Builds relationships with Sponsors, Reviewers, agencies and partners.
• Facilitates MAC related meetings and updates.
• Resolves stakeholder concerns and escalates when needed.
• Trains stakeholders on the MAC process.

Skills

Negotiation

Persuasion

Collaboration

Analytical judgment

Interpersonal communication

Management interface

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen is seeking a Materials Compliance Manager to oversee MAC review and approval to ensure compliant messaging to the public. You will report to the MAC leadership in Regulatory Affairs and coordinate with sponsors, reviewers, and external partners.

You will drive MAC process improvements, manage stakeholder expectations, and ensure adherence to MAC policies and regulatory requirements across assigned business units.