DIRECTOR REGULATORY AFFAIRS GLOBAL REGULATORY LEAD, GLOBAL REGULATORY STRATEGY

Company: Allergan
Location: Chicago
Posted on: November 13, 2024

Job Description:

Job Description
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• Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.
• Responsible for leading the Global Regulatory Product Team (GRPT), developing, and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.
• Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers.
• May lead the Labeling Regulatory Strategy Team (LRST), and serve as the primary regulatory interface with AST and supporting teams.
• Manages compounds through all phases of development, including post approval and throughout the life cycle of the product.
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.Qualifications
  • Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
  • Required Experience: 5-7+ years regulatory and drug development experience.
  • Proven 5+ years in a strategic leadership role with strong project management skills.
  • Preferred Experience: 7-10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan.
  • Location: Preferred location is Lake County, IL
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