Director of Regulatory Affairs

The Opportunity: Director of Regulatory Affairs

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.

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  Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
  
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  Motivate, mentor and develop direct reports to ensure development and performance.
  
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  Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.
  
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  Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.
  
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  Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.
  
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  Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.
  

Required Skills, Experience and Education:

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  Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
  
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  Proven success in developing and delivering global regulatory strategies and submissions.
  
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  Demonstrated success in leading health authority interactions and negotiations.
  
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  Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.
  
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  Strong track record in alliance management, coordinating with external development or commercialization partners.
  
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  Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.
  
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  Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
  

Preferred Skills:

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  An advanced degree is desirable.
  
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  Experience with dose optimization in oncology.
  
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  Prior NDA experience is highly preferred.