Rare Disease Regulatory Lead — US Strategy & Submissions

Amgen Inc.; United States; Remote; USD 150,000 - 230,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Discretionary annual bonus

Flexible work models

Comprehensive benefits

Job summary

Amgen Inc. is seeking a Regulatory Affairs Manager - US Regulatory Lead, Rare Disease. This role focuses on ensuring regulatory compliance, planning strategies, and managing submissions for Amgen products in the United States.

You will collaborate with federal, state, and local agencies, lead regulatory activities (e.g., IND development), and guide labeling and compliance. The position emphasizes leadership and cross-functional collaboration within a global organization.

Qualifications

• Basic Qualifications reflect advanced degrees or equivalent regulatory experience
• Qualifications cover US regulatory activities, IND development, and submissions
• Experience with global/regional regulatory strategy and agency interactions preferred

Responsibilities

• Ensure compliance with US regulations and laws for assigned products
• Plan and execute regulatory strategies for product(s) in country(ies)
• Prepare and manage local regulatory submissions in line with standards
• Provide guidance to optimize product development and regulatory approvals
• Support local regulatory product compliance and labeling input

Skills

Regulatory affairs experience

IND submissions

Regulatory strategy

Agency liaison

Project management

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Associates degree + 8 years experience

High school diploma / GED + 10 years experience

Job description

Amgen Inc. is seeking a Regulatory Affairs Manager - US Regulatory Lead, Rare Disease. This role focuses on ensuring regulatory compliance, planning strategies, and managing submissions for Amgen products in the United States.

You will collaborate with federal, state, and local agencies, lead regulatory activities (e.g., IND development), and guide labeling and compliance. The position emphasizes leadership and cross-functional collaboration within a global organization.