Regulatory Affairs Director

AstraZeneca

Gaithersburg, MD, USA
Base: $186,232.80 - $279,349.20; bonus/equity: sho...
Lead cross functional regulatory teams
Develop global regulatory strategy
Manage major regulatory submissions
The Regulatory Affairs Director provides strategic and operational regulatory leadership to the development and commercialization of assigned oncology products

Job Summary

  • The Regulatory Affairs Director provides strategic and operational regulatory leadership to the development and commercialization of assigned oncology products.
  • The role involves leading cross-functional teams in major regulatory submissions, health authority interactions, and securing approvals for life-changing medicines.
  • AstraZeneca offers a competitive salary ranging from $186,232.80 to $279,349.20 along with comprehensive benefits including 401(k) and health coverage.

Matching Summary

The Regulatory Affairs Director provides strategic and operational regulatory leadership to the development and commercialization of assigned oncology products.

Salary

Base: $186,232.80 - $279,349.20; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program available; Benefits: Qualified retirement program (401k), paid vacation, holidays, leaves, medical, dental, and vision coverage.

Skills & Requirements

Must-have

  • Lead cross functional regulatory teams
  • Develop global regulatory strategy
  • Manage major regulatory submissions
  • Conduct health authority interactions
  • Negotiate with health authorities

Nice-to-have

  • Strategic thinking and influencing skills
  • Experience in phase 3 design
  • Knowledge of benefit risk profile
  • Mentorship and team leadership
  • Innovation and initiative

Key Requirements

  • Bachelor's degree in science related field
  • At least 3 years of Regulatory strategy experience
  • Solid knowledge of regulatory affairs in therapeutic area
  • Experience with major HA interactions
  • Demonstrated competencies in strategic thinking and leadership

Work Rights

Not specified

Tailored Resume

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