Associate Director, Global Regulatory Affairs - Gi & Inflammation

Takeda

Boston, MA, USA
Base: $154,400.00 - $242,550.00; bonus/equity: eli...
Hybrid
6+ years pharmaceutical industry experience
4+ years regulatory experience
Lead global regulatory teams and strategies
The role defines and leads global regulatory strategies to ensure program success for complex projects within the Gi & Inflammation portfolio

Job Summary

  • The role defines and leads global regulatory strategies to ensure program success for complex projects within the Gi & Inflammation portfolio.
  • Candidates must be accountable for all US FDA submissions and approvals or oversee direct reports responsible for these critical activities.
  • The position offers a competitive base salary range of $154,400.00 to $242,550.00 along with comprehensive benefits including medical, dental, vision, and 401(k) matching.

Matching Summary

The role defines and leads global regulatory strategies to ensure program success for complex projects within the Gi & Inflammation portfolio.

Salary

Base: $154,400.00 - $242,550.00; Bonus/Equity: Eligible for short-term and/or long-term incentives; Benefits: Medical, dental, vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off

Skills & Requirements

Must-have

  • 6+ years pharmaceutical industry experience
  • 4+ years regulatory experience
  • Lead global regulatory teams and strategies
  • Manage US FDA submissions and approvals
  • Direct point of contact with health authorities

Nice-to-have

  • Experience in licensing due diligence
  • Knowledge of EU, Canada, and ROW regulations
  • Strong negotiation and communication skills
  • Ability to anticipate regulatory trends
  • Experience with joint regulatory/HTA interactions

Key Requirements

  • Bachelor's degree in scientific discipline (Advanced degree preferred)
  • 6+ years pharmaceutical industry experience
  • 4+ years specific regulatory experience
  • Solid working knowledge of drug development process
  • US work authorization required for Boston location

Work Rights

Not specified

Tailored Resume

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