Early Development Global Regulatory Lead

argenx

Competitive salary pyckage; benefits: broad range ...
Not specified (assumed office-based due to role description).
15 years regulatory affairs experience
5-7 years global leadership roles
Fda ema pmda regulatory expertise
Argenx is seeking an Early Development Global Regulatory Lead to support its expanding pipeline in autoimmune disease treatments. The ideal candidate will have extensive regulatory affairs experience, particularly in global leadership roles, and a strong understanding of drug development processes

Job Summary

  • The role serves as a key strategic advisor to develop sound global regulatory strategies for early-stage assets.
  • Candidates must have extensive experience interacting with major regulatory authorities like the FDA and EMA.
  • The position offers a competitive salary package and opportunities to make an impact in a dynamic work environment.

Matching Summary

Match Score: 85

Argenx is seeking an Early Development Global Regulatory Lead to support its expanding pipeline in autoimmune disease treatments. The ideal candidate will have extensive regulatory affairs experience, particularly in global leadership roles, and a strong understanding of drug development processes.

Salary

Competitive salary package; Benefits: broad range of benefits; Equity/Bonus: Not specified

Skills & Requirements

Must-have

  • 15 years regulatory affairs experience
  • 5-7 years global leadership roles
  • FDA EMA PMDA regulatory expertise
  • Orphan drugs development knowledge
  • Scientific advice and IND filings

Nice-to-have

  • PhD or PharmD degree preferred
  • Experience in rapidly growing pharma
  • Patient-centric regulatory strategy
  • Strong cross-functional collaboration
  • Mentoring and team building skills

Key Requirements

  • Minimum 15 years regulatory affairs experience
  • 5-7 years in global leadership roles
  • PhD or PharmD preferred qualification
  • Expertise in orphan drugs landscape

Work Rights

Not specified

Tailored Resume

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