Director, Regulatory Cmc Device Leader

argenx

Onsite
Global regulatory cmc strategy leadership
21 cfr part 4 and eu mdr expertise
Device and combination product submissions
The role involves leading global regulatory CMC strategies for combination products to ensure successful approvals in key markets

Job Summary

  • The role involves leading global regulatory CMC strategies for combination products to ensure successful approvals in key markets.
  • Candidates must provide technical guidance on integrating global requirements into regulatory submissions aligned with FDA and EMA guidelines.
  • The position requires acting as a key interface for cross-functional teams including Clinical, Supply Chain, and Quality departments.

Matching Summary

The role involves leading global regulatory CMC strategies for combination products to ensure successful approvals in key markets.

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • 21 CFR Part 4 and EU MDR expertise
  • Device and combination product submissions
  • Module 3 technical documentation authoring
  • Health Authority interaction management
  • ISO 14971 risk management application

Nice-to-have

  • Cross-functional team collaboration skills
  • Strategic stakeholder management abilities
  • Mentoring regulatory professionals experience
  • Veeva RIMS and Quality Docs proficiency
  • External industry forum participation

Key Requirements

  • Master degree or PhD in biotechnology
  • Pharmaceutical/biotechnology industry experience
  • Leadership in Regulatory CMC Device area
  • Demonstrated organizational skills
  • Experience with design control processes

Work Rights

Not specified

Tailored Resume

Cover Letter