Regulatory Director, Remote – Inflammation & Rare Disease

Work From Anywhere

Washington (District of Columbia)

Hybrid

USD 180,000 - 240,000

Full time

3 days ago
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Job summary

Amgen is seeking a Global Regulatory Affairs Director for Inflammation and Rare Disease in Washington, DC. This remote, full-time role leads the Global Regulatory Team to craft regulatory strategies, guide product development, and manage global submissions across regions.

The candidate should have advanced degrees in biotech/science with substantial regulatory experience and the ability to navigate complex regulatory environments and cross-functional teams.

Qualifications

  • Doctorate degree in biotech or science with regulatory experience (4+ years).
  • Master’s degree with 7+ years in biotech or science, regulatory focus.
  • Bachelor’s degree with 9+ years of regulatory experience in biotech or science.

Responsibilities

  • Develop global regulatory product strategy and lead Global Regulatory Teams (GRTs).
  • Represent Regulatory on product teams and governance bodies; input into Global Strategic Plan.
  • Develop registration strategies for regulatory approval and product labeling; lead global filings.

Skills

Leadership
Communication
Scientific communication
Strategic thinking
Planning and organizing
Decision making under ambiguity

Education

Doctorate degree
Master’s degree
Bachelor’s degree

Job description

Amgen is seeking a Global Regulatory Affairs Director for Inflammation and Rare Disease in Washington, DC. This remote, full-time role leads the Global Regulatory Team to craft regulatory strategies, guide product development, and manage global submissions across regions.

The candidate should have advanced degrees in biotech/science with substantial regulatory experience and the ability to navigate complex regulatory environments and cross-functional teams.

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