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Director of Global Regulatory Affairs

2 months ago

North Chicago Illinois, United States AbbVie Full time
Job Summary

The Director of Global Regulatory Strategy is a key member of the AbbVie team, responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.

Key Responsibilities
  • Develop and implement global regulatory strategies to achieve business objectives for development and marketed products.
  • Lead the Global Regulatory Product Team (GRPT) to develop creative global strategies in line with applicable regulations.
  • Interface with the Labeling Regulatory Strategy Team (LRST) and AbbVie's cross-functional teams to lead and support company objectives.
  • Proactively anticipate and mitigate regulatory risks, ensuring compliance with global regulatory requirements.
  • Manage compounds through all phases of development, including post-approval and throughout the life cycle of the product.
  • Develop and implement acceleration strategies, managing projects and necessary documentation of regulatory strategies.
  • Represent AbbVie's regulatory position in interactions at Joint Governance.
  • Participate in and take leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.
Requirements
  • Excellent understanding of drug development and leadership behaviors consistent with level.
  • Ability to analyze legislation, regulations, and guidance, providing analysis to the organization.
  • Worldwide accountability for assigned products.
  • Ability to present meaningful regulatory assessments and recommendations to executive management.
  • Strong communication and leadership skills.