Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

AstraZeneca

Base: $218,058.40 - $327,087.60; bonus/equity: sho...
Cell and gene therapy regulatory strategy
Bla submission and approval experience
Multiple myeloma disease area knowledge
This role leads the development and implementation of global regulatory strategy for high-complexity Cell and Gene Therapy products in Oncology

Job Summary

  • This role leads the development and implementation of global regulatory strategy for high-complexity Cell and Gene Therapy products in Oncology.
  • The Senior Director serves as a Global Regulatory Lead responsible for delivering efficient approvals with competitive labeling while managing multiple indications.
  • Employees benefit from a competitive salary range, short-term incentives, equity programs, and a flexible work environment requiring three days of office presence weekly.

Matching Summary

This role leads the development and implementation of global regulatory strategy for high-complexity Cell and Gene Therapy products in Oncology.

Salary

Base: $218,058.40 - $327,087.60; Bonus/Equity: Short-term incentive bonus and long-term equity program available; Benefits: 401(k), paid vacation, health, dental, and vision coverage

Skills & Requirements

Must-have

  • Cell and gene therapy regulatory strategy
  • BLA submission and approval experience
  • Multiple myeloma disease area knowledge
  • Global regulatory stakeholder management
  • Leading cross-functional product teams

Nice-to-have

  • FDA advisory committee experience
  • EMA oral explanation experience
  • Autoimmune condition product development
  • Business alliance due diligence
  • Coaching and mentorship skills

Key Requirements

  • Advanced degree in science related field
  • Seven to ten years of relevant experience
  • Proven success in CGT regulatory strategy
  • Experience with multiple myeloma product development
  • Prior experience in Oncology small molecules and biologics

Work Rights

Not specified

Tailored Resume

Cover Letter