Early Development Global Regulatory Lead

argenx

Not specified; competitive salary pyckage; broad r...
Not specified
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 early-stage pipeline in immunology. The role involves strategic regulatory oversight and collaboration across teams to facilitate the development of innovative therapies for autoimmune diseases

Job Summary

  • The role serves as a key strategic advisor to support accelerated, 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 environment fostering innovation across all corners of a science-based start-up culture.

Matching Summary

Match Score: 85

Argenx is seeking an Early Development Global Regulatory Lead to support its expanding early-stage pipeline in immunology. The role involves strategic regulatory oversight and collaboration across teams to facilitate the development of innovative therapies for autoimmune diseases.

Salary

Not specified; Competitive salary package; Broad range of benefits included

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

  • Experience in rapidly growing pharma
  • PhD or PharmD preferred qualification
  • Strong stakeholder relationship building
  • Innovative patient-centric strategies
  • Mentoring and team development skills

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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