Director, RA Global Regulatory Strategy

Added
3 minutes ago
Type
Full time
Salary
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Related skills

regulatory affairs lifecycle management drug development regulatory compliance global regulatory strategy
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๐Ÿ“‹ Description

  • Develop and implement global regulatory strategies to secure and maintain market approval.
  • Lead the Global Regulatory Product Team (GRPT) and may lead Area Lead/Labeling Regulatory Strategy
  • Ensure strategic messaging in global regulatory dossiers and responses.
  • Interact with AST and supporting teams as primary regulatory interface when needed.
  • Oversee lifecycle management of compounds across development and post-approval.
  • Drive acceleration strategies under supervision.

๐ŸŽฏ Requirements

  • Bachelor's in life sciences; advanced degree preferred.
  • 5+ years regulatory experience; 3+ years in strategic leadership; matrix environment experience.
  • Strong communication and negotiation skills; business acumen under pressure.
  • Preferred: 7+ years in pharmaceutical regulatory activities across regions; global regulatory

๐ŸŽ Benefits

  • Comprehensive benefits package; PTO; medical/dental/vision; 401(k).
  • Long-term incentive programs eligibility.
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