Associate Director, Global Regulatory Affairs Marketed Products

Takeaweigh

Boston, MA, US
Base: $153,600.00 - $241,340.00; bonus/equity: not...
Hybrid
Global regulatory strategies
Regulatory submissions
Fda submissions and approvals
Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects

Job Summary

  • Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
  • Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors.
  • At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Matching Summary

Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.

Salary

Base: $153,600.00 - $241,340.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits

Skills & Requirements

Must-have

  • Global regulatory strategies
  • Regulatory submissions
  • FDA submissions and approvals
  • Drug development process
  • Regulatory requirements

Nice-to-have

  • Influencing the field
  • Patient-focused company
  • Collaborative workplace
  • Transformative therapies

Key Requirements

  • BSc Degree or BA accepted
  • 8+ years pharmaceutical industry experience
  • 6 years regulatory experience
  • Solid working knowledge of drug development
  • Knowledge of FDA, EU, Canada, ROW

Work Rights

Not specified

Tailored Resume

Cover Letter