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Regulatory Project Manager

hace 4 semanas

Pájaros Barrio, Puerto Rico Neogene Therapeutics A tiempo completo
Regulatory Project Manager

We are seeking a highly skilled Regulatory Project Manager to join our team at Neogene Therapeutics. As a key member of our regulatory affairs team, you will be responsible for developing and maintaining detailed project plans and timelines for deliverables, including briefing books, INDs, CTAs, and other projects.

Key Responsibilities:

  • Create detailed project plans for regulatory deliverables in support of health authority interactions
  • Collaborate with cross-functional teams to drive timeline adherence and successful on-time completion of multiple documents
  • Facilitate communication between functional areas to maintain successful timelines
  • Understand and communicate regulatory strategy and project plans cross-functionally
  • Analyze current processes and workflows to provide suggestions for process optimization

Requirements:

  • BA/BS degree or equivalent degree in a related field
  • 3+ years of experience in regulatory project management or 5+ years of experience in regulatory affairs strategy and 2+ years in project management
  • Strong working knowledge of relevant software platforms
  • Excellent interpersonal, organizational, written and oral communication skills
  • Able to effectively communicate progress toward milestones, opportunities, and risks to all stakeholders

What We Offer:

  • Short-term incentive bonus opportunity
  • Equity-based long-term incentive program
  • 401(k) plan
  • Paid vacation and holidays; paid leaves
  • Health benefits including medical, prescription drug, dental, and vision coverage

About Us:

Neogene Therapeutics is a company that values diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be.