Regulatory

  • location: Deerfield, IL
  • type: Permanent
  • salary: $305,000 - $375,000 per year
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job description

Regulatory

Vice President, Regulatory Affairs Clinical

Responsibilities:

  • Provide Leadership and oversight of the Clinical Regulatory Affairs department.
  • Determine overall regulatory strategy regarding clinical protocol development and pathways to marketing approval.
  • Work closely with cross functional teams to ensure development programs are aligned with commercial needs.
  • Build a department to support an expanding pipeline of products in development and on the market.
  • Work closely with other functions within Regulatory Affairs.
  • Initiate and maintain effective partnerships with key functions (Clinical Development, Medical Affairs, Global Drug Safety, and Clinical Operations).
  • Develop and execute sound regulatory decisions and justifications.
  • Provide direct supervision of individuals including mentoring, performance management and staffing decisions.
Qualifications:

  • Bachelor's degree or country equivalent. Higher degree will be an advantage; Minimum 20+ years in pharmaceutical industry, with increasing levels of expertise/experience.
  • 15+ years of experience in Regulatory Affairs.
  • International experience/exposure preferred.
  • Proven regulatory leadership experience in a cross-functional role with significant product development experience.
  • Established understanding of product registration processes .
  • Strong technical knowledge of clinical development.
  • Strong knowledge and interest in the evolving landscape of novel clinical development programs.
  • Experience with rare diseases preferable.
  • Experience with breakthrough therapy designation products preferable.
  • Experience leading transformational change within an organization is highly desirable.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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