Job Description

Amgen seeks a Regulatory Affairs Director to lead global regulatory strategy for inflammation and rare disease products. The role involves directing regulatory teams, developing registration strategies, and managing worldwide regulatory submissions and agency interactions throughout the product lifecycle.

Responsibilities

• Develop and execute global regulatory product strategy for assigned molecules
• Lead global regulatory teams and represent regulatory function on product teams
• Develop registration strategies and plans to achieve regulatory approval and labeling
• Lead planning and implementation of global regulatory filings and submissions
• Monitor global regulations and assess impact on product development strategy

Requirements

• Doctorate degree and 4 years regulatory experience in biotech or science
• Or Master's degree and 7 years regulatory experience in biotech or science
• Or Bachelor's degree and 9 years regulatory experience in biotech or science
• Leadership ability and team-building skills
• Strong oral and written communication capabilities
• Ability to understand and communicate scientific and clinical information
• Strategic planning and conflict resolution skills

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