US Regulatory Lead, Rare Disease Regulatory Affairs Manager

Amgen Inc.; Washington (District of Columbia); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Bonuses & incentives

Stock-based incentives

Flexible work models

Job summary

Amgen Inc. is seeking a Regulatory Affairs Manager – US Regulatory Lead, Rare Disease, to drive regulatory strategies for assigned products in the United States. You will coordinate with federal, state, and local agencies to ensure compliance and timely approvals.

The role involves leading regulatory submissions, interacting with agencies, and contributing to global plans and labeling. Qualifications include advanced degrees with substantial regulatory experience and excellent cross-functional

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.
• Assist the GRL by preparing supportive documentation for regulatory deliverables and managing responses to agency questions.
• Provide primary authorship to routine regulatory correspondence.

Education

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

Job description

Amgen Inc. is seeking a Regulatory Affairs Manager – US Regulatory Lead, Rare Disease, to drive regulatory strategies for assigned products in the United States. You will coordinate with federal, state, and local agencies to ensure compliance and timely approvals.

The role involves leading regulatory submissions, interacting with agencies, and contributing to global plans and labeling. Qualifications include advanced degrees with substantial regulatory experience and excellent cross-functional