Global Regulatory Lead

2 weeks ago


Uxbridge, United Kingdom Bristol Myers Squibb Full time

Transforming Patients' Lives through Science

Bristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Global Regulatory Lead to join our Oncology Drug Development team.

Key Responsibilities

  • Develop and implement global regulatory strategies for Oncology drug development programs.
  • Lead cross-functional teams to ensure regulatory compliance and successful product launches.
  • Collaborate with global regulatory teams to develop and maintain regulatory knowledge and expertise.
  • Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports, and summary documents.
  • Ensure consistent positions are presented in responses to global health authority queries.

Requirements

  • Ph.D., M.D., PharmD, MS, or BS in a relevant scientific field.
  • Significant experience in regulatory affairs, with a strong understanding of Oncology drug development and regulatory policies.
  • Excellent leadership and communication skills, with the ability to drive quality decision-making and facilitate issue resolution.
  • Experience in developing and documenting regulatory strategies, with a strong understanding of clinical plans and marketing objectives.

About Bristol Myers Squibb

Bristol Myers Squibb is a diverse and inclusive company that values innovation, urgency, accountability, inclusion, and integrity. We are committed to transforming patients' lives through science and are seeking talented individuals to join our team.



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