Senior US Regulatory Strategy Lead

BioSpace; Washington (District of Columbia); On-site; USD 150,000 - 190,000; Full time

Job summary

Amgen is seeking a US Regulatory Lead to plan and execute regulatory strategies for its products across the United States. You will coordinate with cross‑functional teams to manage submissions, labeling, and lifecycle activities while interfacing with regulatory agencies.

The role requires extensive US regulatory experience, leadership skills, and a strong understanding of FDA processes to drive timely approvals and ongoing compliance.

Qualifications

• Doctorate degree required for regulatory leadership.
• Experience in US regulatory strategies and submissions preferred.
• Strong leadership and cross-functional collaboration skills required.
• Excellent communication and negotiation abilities.
• In-depth knowledge of US regulatory landscape and FDA processes.

Responsibilities

• Lead regulatory strategies for Amgen products in the US.
• Plan and manage regulatory submissions and lifecycle activities.
• Coordinate with global teams on regulatory plans and labeling.
• Interact with US regulatory authorities and respond to inquiries.
• Ensure local labeling and product compliance with all regulations.
• Mentor junior regulatory staff and drive process improvements.

Skills

US Regulatory experience

Leadership experience

Regulatory submissions

Communication skills

Drug development knowledge

FDA familiarity

Education

Doctorate degree

Masters degree + 3 years US Regulatory experience

Bachelors + 5 years US Regulatory experience

Associates + 10 years US Regulatory

High school diploma / GED + 12 years US Regulatory

Job description

Amgen is seeking a US Regulatory Lead to plan and execute regulatory strategies for its products across the United States. You will coordinate with cross‑functional teams to manage submissions, labeling, and lifecycle activities while interfacing with regulatory agencies.

The role requires extensive US regulatory experience, leadership skills, and a strong understanding of FDA processes to drive timely approvals and ongoing compliance.