Regulatory Affairs Director

AstraZeneca

Gaithersburg, MD, United States
Base: $186,232.80 - $279,349.20; bonus/equity: sho...
Lead cross functional teams in major regulatory submissions
Develop regional or global regulatory strategy
Health authority engagement strategy and interaction plan
The Regulatory Affairs Director provides strategic and operational leadership to the development, commercialization, and life cycle management of assigned oncology products

Job Summary

  • The Regulatory Affairs Director provides strategic and operational leadership to the development, commercialization, and life cycle management of assigned oncology products.
  • The role involves leading cross-functional teams in major regulatory submissions, health authority interactions, and securing approvals for rapid approval with competitive labeling.
  • AstraZeneca offers a competitive salary ranging from $186,232.80 to $279,349.20 along with short-term incentives, equity-based long-term programs, and comprehensive benefits.

Matching Summary

The Regulatory Affairs Director provides strategic and operational leadership to the development, commercialization, and life cycle management 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: 401(k), paid vacation, holidays, leaves, medical, dental, vision coverage

Skills & Requirements

Must-have

  • Lead cross functional teams in major regulatory submissions
  • Develop regional or global regulatory strategy
  • Health authority engagement strategy and interaction plan

Nice-to-have

  • Strategic thinking and influencing skills
  • Experience with phase 3 design interactions
  • Inclusive and diverse team environment

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
  • Previous demonstrated experience of regulatory drug development
  • Experience with major HA interactions

Work Rights

Not specified

Tailored Resume

Cover Letter