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Associate Director, Regulatory Project Manager

ma • Posted 5 days ago
Onsite Full Time Management & Operations

  • Lead end-to-end project management of regulatory initiatives and improvement projects (initiation through closure) within budget, scope, and timelines.
  • Oversee regulatory submissions per CSL’s Global Submission Management Process.
  • Manage improvement projects portfolio in alignment with GRA strategy and executive priorities.
  • Mentor junior project managers and support training on submission processes and tools.

Requirements

  • Bachelor’s degree in Life Sciences or Business required; advanced degree (MSc, PhD, MBA) and PMP certification preferred.
  • 7+ years of experience in pharma/biotech industry with a focus on biologics and regulatory affairs.
  • 7+ years’ experience managing global, cross-functional projects in a matrix environment.
  • Strong knowledge of global regulatory submission processes, drug development lifecycle, and project governance.
  • Demonstrated success in delivering complex projects on time and within scope.

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