US Regulatory Lead, Rare Disease — Regulatory Affairs

Amgen Inc.; United States; Remote; USD 113,000 - 153,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision insurance

Life & disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Paid time off

Flexible work model

Job summary

Amgen Inc. is seeking a Regulatory Affairs Manager - US Regulatory Lead, Rare Disease, to drive regulatory strategies for Amgen products in the U.S. You will collaborate with federal, state, and local agencies to ensure compliance and timely approvals.

The role covers IND development/submission, global regulatory input, and preparation of regulatory documents. Strong leadership and communication skills are essential to navigate complex regulatory landscapes.

Qualifications

• Doctorate or Master plus regulatory experience required.
• Bachelor’s plus regulatory experience acceptable.
• All candidates should have relevant regulatory affairs experience or advanced degree equivalents.

Responsibilities

• Support Global Regulatory Team in US activities (IND development/submission).
• Act as primary contact with regulatory agencies.
• Guide local regulatory development and approvals.
• Plan/manage local regulatory submissions per standards and requirements.
• Ensure local regulatory product compliance and labeling aligned with laws.
• Assist in preparing regulatory documentation for deliverables.
• Draft routine regulatory correspondence.

Skills

Regulatory affairs knowledge

Leadership

Strategic thinking

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associates degree

High school diploma

Job description

Amgen Inc. is seeking a Regulatory Affairs Manager - US Regulatory Lead, Rare Disease, to drive regulatory strategies for Amgen products in the U.S. You will collaborate with federal, state, and local agencies to ensure compliance and timely approvals.

The role covers IND development/submission, global regulatory input, and preparation of regulatory documents. Strong leadership and communication skills are essential to navigate complex regulatory landscapes.