Regulatory Affairs Lead — US Rare Disease Strategy

BioSpace; Washington (District of Columbia); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

A comprehensive employee benefits plan

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models where possible

Job summary

Amgen is seeking a Regulatory Affairs Manager - US Regulatory Lead, Rare Disease, to drive regulatory strategies and submissions for Amgen products in the United States. You will collaborate with the Global Regulatory Team and regulators to ensure compliant product development and approvals.

The role requires leading regulatory activities, preparing submissions, and providing regulatory guidance, with opportunities for professional growth within a collaborative, science-driven culture.

Qualifications

• Doctorate, Masters, Bachelor’s, or equivalent with regulatory experience.
• Experience leading regulatory strategies for products in US/regulatory environments.
• Ability to plan and manage regulatory submissions and interact with agencies.
• Strong leadership and cross-functional collaboration in a regulatory context.
• Excellent written and verbal communication for regulatory documentation.

Responsibilities

• Plan and execute regulatory strategies for Amgen products in the country(ies).
• Lead regulatory submissions and manage timelines in line with local requirements.
• Serve as main point of contact with regulatory agencies.
• Contribute to global regulatory strategy and labeling discussions.
• Prepare primary authorship for routine regulatory correspondence.

Skills

Regulatory strategy

Regulatory submissions

Global regulatory teamwork

Regulatory correspondence

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associates degree

High school diploma

Job description

Amgen is seeking a Regulatory Affairs Manager - US Regulatory Lead, Rare Disease, to drive regulatory strategies and submissions for Amgen products in the United States. You will collaborate with the Global Regulatory Team and regulators to ensure compliant product development and approvals.

The role requires leading regulatory activities, preparing submissions, and providing regulatory guidance, with opportunities for professional growth within a collaborative, science-driven culture.