Associate Regulatory Affairs Director

AstraZeneca's Alexion division

Base: $135,624.80 - $203,437.20 usd; bonus/equity:...
Regulatory submission strategy
Project management capabilities
Lead regulatory applications
The Associate Regulatory Affairs Director is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, contributing to regulatory submission strategy and managing regulatory applications through approval

Job Summary

  • The Associate Regulatory Affairs Director is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, contributing to regulatory submission strategy and managing regulatory applications through approval.
  • The role involves providing regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams, working flexibly within and across regions to ensure business objectives are met.
  • The company offers a competitive annual base pay ranging from $135,624.80 - $203,437.20 USD, with bonus/equity opportunities and comprehensive benefits including a 401(k) plan, paid time off, and health coverage.

Matching Summary

The Associate Regulatory Affairs Director is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, contributing to regulatory submission strategy and managing regulatory applications through approval.

Salary

Base: $135,624.80 - $203,437.20 USD; 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

  • Regulatory submission strategy
  • Project management capabilities
  • Lead regulatory applications
  • Regulatory expertise and guidance
  • Cross-functional teams
  • Biopharmaceutical industry experience

Nice-to-have

  • Bold thinking
  • Inspire life-changing medicines
  • Push boundaries in rare disease
  • Translate complex biology
  • Meet unmet medical needs

Key Requirements

  • Bachelor's degree in science or related field
  • 4+ years of regulatory experience
  • Extensive regulatory experience in biopharmaceutical industry
  • Thorough knowledge of drug development
  • Strong project management skills
  • Leadership skills
  • Master's degree in science or related field (preferred)
  • 7 years of regulatory experience (preferred)

Work Rights

Not specified

Tailored Resume

Cover Letter