Regulatory Affairs Manager, US – Rare Disease

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

Benefits offered by this job

Health benefits

Bonus program

Stock-based incentives

Flexible work models

Time-off plans

Job summary

Amgen seeks a Regulatory Affairs Manager to lead US regulatory efforts for Rare Disease products, ensuring compliance and strategic submissions across assigned programs.

You will coordinate with federal, state, and local agencies, manage local labeling, and contribute to global regulatory plans while advancing patient-focused therapies. Strong leadership and regulatory expertise are essential.

Qualifications

• Doctorate degree
• Master’s degree and 2 years of Regulatory Affairs experience
• Bachelor’s degree and 4 years of Regulatory Affairs experience
• Associates degree and 8 years of Regulatory Affairs experience
• High school diploma / GED and 10 years of Regulatory Affairs experience

Responsibilities

• Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission).
• Act as the point of contact with regulatory agencies.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure and support local regulatory product compliance (eg, agency commitments).
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc.
• Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions.
• Provide primary authorship to routine regulatory correspondence.

Education

Doctorate degree

Master’s degree + 2 years of Regulatory Affairs experience

Bachelor’s degree + 4 years of Regulatory Affairs experience

Associates degree + 8 years of Regulatory Affairs experience

High school diploma / GED + 10 years of Regulatory Affairs experience

Job description

Amgen seeks a Regulatory Affairs Manager to lead US regulatory efforts for Rare Disease products, ensuring compliance and strategic submissions across assigned programs.

You will coordinate with federal, state, and local agencies, manage local labeling, and contribute to global regulatory plans while advancing patient-focused therapies. Strong leadership and regulatory expertise are essential.