Director, Global Regulatory Lead

BeOne Medicines Ltd

Remote
$176,000.00 - $236,000.00 annually; bonus/equity: ...
Global regulatory strategies
Drug development process
Health authority interactions
The Director, Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives

Job Summary

  • The Director, Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.
  • The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met while leveraging expedited pathways where appropriate.
  • BeOne is committed to fair and equitable compensation practices, offering a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

The Director, Global Regulatory Lead will be responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.

Salary

$176,000.00 - $236,000.00 annually; Bonus/Equity: Annual bonus plan, discretionary equity awards, Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness

Skills & Requirements

Must-have

  • Global regulatory strategies
  • Drug development process
  • Health Authority interactions
  • Regulatory submission packages
  • Lifecycle management

Nice-to-have

  • Scientific and business professionals
  • Collaborative spirit
  • Bold ingenuity
  • Results-oriented
  • Analytical thinking

Key Requirements

  • BS with 10+ years, MS with 7+ years or PhD/MD/PharmD with 5+ years of experience
  • 5+ years in a Regulatory capacity
  • Experience as a lead in Regulatory Affairs across two or more major geographic areas
  • Prior experience with both small molecules and biologics
  • Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs

Work Rights

Not specified

Tailored Resume

Cover Letter