Early Development Global Regulatory Lead

argenx

Competitive salary pyckage; broad range of benefit...
Not specified (assumed to be onsite or hybrid based on typical biotech roles).
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 drive regulatory strategies for its expanding pipeline of autoimmune therapies. The ideal candidate will have significant experience in regulatory affairs and leadership, particularly in global markets, and will play a key role in ensuring successful early-stage drug development

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 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: 85

Argenx is seeking an Early Development Global Regulatory Lead to drive regulatory strategies for its expanding pipeline of autoimmune therapies. The ideal candidate will have significant experience in regulatory affairs and leadership, particularly in global markets, and will play a key role in ensuring successful early-stage drug development.

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

Nice-to-have

  • PhD or PharmD degree preferred
  • Experience in rapidly growing organizations
  • Strong stakeholder relationship building
  • Patient-centric regulatory strategy focus
  • Innovative and pragmatic leadership style

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter