Early Development Global Regulatory Lead

argenx

Competitive salary pyckage; broad range of benefit...
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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 join their expanding regulatory team in Europe. This role involves creating and implementing regulatory strategies for early-stage drug development, with a strong emphasis on patient-centricity and collaboration across teams. **

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 biotech company.

Matching Summary

Match Score: 75

** Argenx is seeking an Early Development Global Regulatory Lead to join their expanding regulatory team in Europe. This role involves creating and implementing regulatory strategies for early-stage drug development, with a strong emphasis on patient-centricity and collaboration across teams. **

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
  • Early clinical development strategy
  • Scientific advice and IND filings

Nice-to-have

  • Experience in rapidly growing organizations
  • Orphan drug development knowledge
  • Strong stakeholder relationship building
  • Patient-centric regulatory approach
  • Innovative strategic thinking skills

Key Requirements

  • Minimum 15 years regulatory experience
  • 5-7 years global leadership experience
  • PhD or PharmD degree preferred
  • Expertise in FDA and EMA interactions
  • Proven track record in orphan drugs

Work Rights

Not specified

Tailored Resume

Cover Letter