Senior US Regulatory Lead with Flexible Work Options

Regulatory Jobs; United States; Remote; USD 113,000 - 153,000; Full time

Benefits offered by this job

Retirement plan

Medical insurance

Bonus program

Stock incentives

Flexible work model

Job summary

Amgen is seeking a Local Regulatory Representative (Manager) in the United States to lead regulatory strategies for Amgen products, ensuring compliance with local and corporate standards. You will work with cross-functional teams to align local requirements with global plans and prepare regulatory submissions.

Responsibilities include planning submissions, guiding labeling, coordinating with FDA, mentoring junior staff, and contributing to expedited pathways and pediatric plans.

Qualifications

• Doctorate, or Master’s with regulatory experience
• Bachelor’s with regulatory experience
• Associate’s with 10 years regulatory experience
• High school diploma with 12 years regulatory experience
• Leadership experience managing people or teams
• Experience with regulatory submissions and FDA interactions

Responsibilities

• Plan and execute local regulatory strategies for assigned products.
• Manage local regulatory submissions in compliance with standards.
• Create, review, and approve country labeling; own country artwork.
• Collaborate with Global Regulatory teams on study planning and labeling.
• Mentor and advise junior Local Regulatory Representatives.
• Monitor changes in national legislation and external regulatory environment.

Skills

Leadership experience

Teamwork

Communication

Negotiation

Influencing

Education

Doctorate degree

Master's degree + 3 years US Regulatory experience

Bachelor's degree + 5 years US Regulatory experience

Associate's degree + 10 years US Regulatory experience

High school diploma / GED + 12 years US Regulatory experience

Job description

Amgen is seeking a Local Regulatory Representative (Manager) in the United States to lead regulatory strategies for Amgen products, ensuring compliance with local and corporate standards. You will work with cross-functional teams to align local requirements with global plans and prepare regulatory submissions.

Responsibilities include planning submissions, guiding labeling, coordinating with FDA, mentoring junior staff, and contributing to expedited pathways and pediatric plans.