Early Development Global Regulatory Lead

argenx

Not specified; competitive salary pyckage offered;...
Not specified (assumed to be hybrid based on industry norms).
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 the immunology sector. The role involves developing regulatory strategies and collaborating with cross-functional teams to ensure the smooth transition of programs through the regulatory process

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 at least 15 years of regulatory affairs experience within biopharmaceutical organizations, including significant global leadership roles.
  • The position offers the opportunity to work in a dynamic, supportive environment within a successful and rapidly growing biotech company.

Matching Summary

Match Score: 85

Argenx is seeking an Early Development Global Regulatory Lead to support its expanding early-stage pipeline in the immunology sector. The role involves developing regulatory strategies and collaborating with cross-functional teams to ensure the smooth transition of programs through the regulatory process.

Salary

Not specified; Competitive salary package offered; 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 filing experience

Nice-to-have

  • Experience in rapidly growing organizations
  • PhD or PharmD preferred qualification
  • Ability to mentor and coach teams
  • Strategic thinking with execution skills
  • Pragmatic and innovative problem solver

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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