Sr. Director Asset Regulatory Affairs Lead

argenx

Belgium
Base: $268,000.00 - $368,500.00 usd; bonus/equity:...
Fully remote
15 years regulatory affairs experience
Global leadership in biopharma
Fda ema pmda submission expertise
The role serves as a key member of the global regulatory leadership team preparing for the first global marketing application of a late-stage asset

Job Summary

  • The role serves as a key member of the global regulatory leadership team preparing for the first global marketing application of a late-stage asset.
  • Candidates must provide strategic regulatory guidance to drive successful product launches and commercialization activities across multiple indications.
  • The position offers a competitive base salary range of $268,000.00 to $368,500.00 USD along with short-term and long-term incentive programs.

Matching Summary

The role serves as a key member of the global regulatory leadership team preparing for the first global marketing application of a late-stage asset.

Salary

Base: $268,000.00 - $368,500.00 USD; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive package including retirement savings and health benefits

Skills & Requirements

Must-have

  • 15 years regulatory affairs experience
  • Global leadership in biopharma
  • FDA EMA PMDA submission expertise
  • Late stage asset development strategy
  • Orphan and pediatric indication licensure

Nice-to-have

  • Autoimmune neurology or rheumatology background
  • Experience in rapidly growing organizations
  • Strong stakeholder engagement skills
  • Collaborative team culture mindset
  • Pragmatic yet innovative problem solving

Key Requirements

  • Minimum 15 years regulatory affairs experience
  • 5-7 years in global leadership roles
  • PhD or PharmD degree preferred
  • Proven track record with FDA, EMA, and PMDA
  • Experience with biologic drug development

Work Rights

Not specified

Tailored Resume

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