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, EMA, and ISO standards.
  • The position requires acting as the primary interface for cross-functional teams and external organizations to ensure regulatory alignment.

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 section authoring and review
  • ISO 14971 risk management application
  • Health Authority interaction management

Nice-to-have

  • Strategic mindset in dynamic landscape
  • Cross-functional team collaboration skills
  • Mentoring and developing professionals
  • External industry forum participation
  • Continuous improvement mindset
  • Strong stakeholder management abilities

Key Requirements

  • Master degree or PhD in biotechnology
  • Experience in pharmaceutical/biotechnology industry
  • Leadership experience in Regulatory CMC Device area
  • Demonstrated organizational skills in combination products

Work Rights

Not specified

Tailored Resume

Cover Letter