Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

AstraZeneca

CA, United States
Base: $218,058.40 - $327,087.60; bonus/equity: sho...
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Global regulatory strategy for cgt products
Lead health authority meetings
Develop novel regulatory tools and technology
** AstraZeneca is seeking a Senior Regulatory Affairs Director for Oncology Cell & Gene Therapy, responsible for leading global regulatory strategies for complex CGT products. The role involves cross-functional teamwork, stakeholder management, and mentoring, with an emphasis on ensuring efficient regulatory approvals. **

Job Summary

  • The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility.
  • The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
  • At AstraZeneca, Regulatory professionals help turn breakthrough science into real solutions for patients with serious diseases by shaping innovative pathways through complex global requirements.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Senior Regulatory Affairs Director for Oncology Cell & Gene Therapy, responsible for leading global regulatory strategies for complex CGT products. The role involves cross-functional teamwork, stakeholder management, and mentoring, with an emphasis on ensuring efficient regulatory approvals. **

Salary

Base: $218,058.40 - $327,087.60; Bonus/Equity: short-term incentive bonus opportunity, equity-based long-term incentive program; Benefits: qualified retirement program [401(k) plan], paid vacation and holidays, paid leaves, health benefits including medical, prescription drug, dental, and vision coverage

Skills & Requirements

Must-have

  • Global regulatory strategy for CGT products
  • Lead health authority meetings
  • Develop novel regulatory tools and technology
  • Experience with product development for multiple myeloma
  • Oncology (small molecules & biologics) experience preferred

Nice-to-have

  • Experience with FDA advisory committee
  • Experience with EMA oral explanation
  • Experience developing products for autoimmune conditions
  • Experience working on due diligence activities
  • Experience in a business alliance environment

Key Requirements

  • Advanced degree in a science related field
  • Seven-ten years of experience
  • Demonstrated success in cell and/or gene therapy regulatory strategy
  • Deep understanding of global regulatory science
  • Long standing experience of overall drug/biologic development processes
  • Proven experience leading regulatory and cross-functional teams
  • Previous experience in leading major Health Authority interactions

Work Rights

Not specified

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