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Director, Regulatory Affairs Business Development

AbbVie

North Chicago, IL

Director leading regulatory scientific assessment and due diligence for business development activities at a pharmaceutical company. Responsible for evaluating acquisition and licensing opportunities, developing regulatory strategy, managing cross-functional teams, and communicating risk assessments to executive leadership.

Responsibilities

  • Conduct regulatory scientific assessments for in-licensing, out-licensing, and acquisition opportunities
  • Lead cross-functional teams evaluating new business opportunities and formulating regulatory recommendations
  • Develop regulatory strategy and risk mitigation plans supporting development scenarios and financial modeling
  • Negotiate regulatory activities and requirements within business transaction contracts and agreements
  • Manage regulatory budget, internal resources, and external consultants supporting due diligence activities

Requirements

  • Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field
  • 7+ years regulatory affairs experience, including drug development in US and Canada
  • 5+ years in strategic leadership role with strong project management skills
  • Experience in complex matrix environments influencing cross-functional teams
  • Strong communication and negotiation skills with government regulatory agencies
  • Knowledge of global regulatory environments (US, EU, Japan, China) and pharmaceutical guidelines
  • Advanced degree or relevant certification preferred
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Vacancy posted 2 days ago
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