Early Development Global Regulatory Lead

argenx

Competitive salary pyckage; broad range of benefit...
Not specified (assumed to be in-office based on location and role requirements)
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 the growth of its early-stage pipeline in immunology. The ideal candidate will have extensive regulatory affairs experience, especially in global leadership roles, and will contribute to innovative regulatory strategies while fostering a patient-centric approach

Job Summary

  • The role serves as a key strategic advisor to accelerate patient-centric development pathways from pre-nomination through early clinical studies.
  • Candidates must have a minimum of 15 years of regulatory affairs experience within biopharmaceutical organizations with significant global leadership exposure.
  • The position offers the opportunity to work in a dynamic, supportive environment at a successful biotech company fostering innovation across all business corners.

Matching Summary

Match Score: 85

argenx is seeking an Early Development Global Regulatory Lead to support the growth of its early-stage pipeline in immunology. The ideal candidate will have extensive regulatory affairs experience, especially in global leadership roles, and will contribute to innovative regulatory strategies while fostering a patient-centric approach.

Salary

Competitive salary package; Broad range of benefits; 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
  • Cross-functional team collaboration

Nice-to-have

  • Experience in rapidly growing organizations
  • PhD or PharmD degree preferred
  • Patient-centric regulatory strategy
  • Vendor management skills
  • Strong mentorship capabilities
  • Innovative problem solving approach

Key Requirements

  • Minimum 15 years regulatory affairs experience
  • 5-7 years in global leadership roles
  • PhD or PharmD preferred
  • Expertise in FDA, EMA, or PMDA regions
  • Proven track record with orphan drugs

Work Rights

Not specified

Tailored Resume

Cover Letter