Director, Regulatory Cmc Device Leader

argenx.nl

Onsite
Global combination product regulations
Device & combination products
Regulatory cmc strategy
Argenx is seeking a Director, Regulatory CMC Device Leader to lead the regulatory strategies for combination products, ensuring compliance and successful approvals across global markets. The role requires extensive expertise in regulatory affairs, particularly related to device and combination products, and emphasizes collaboration across various internal and external stakeholders

Job Summary

  • Lead the global regulatory CMC strategy for combination products throughout their lifecycle, including early development, registration, post-marketing and compliance management.
  • Provide technical guidance to CMC team and ensure integration of global combination product requirements into regulatory submissions in alignment with 21 CFR Part 4, EU MDR, ISO 14971, and ICH guidelines.
  • Act as the Reg CMC interface on cross-functional combination product teams and establish strong partnerships to ensure collaboration with key internal stakeholders and external organizations.

Matching Summary

Match Score: 85

Argenx is seeking a Director, Regulatory CMC Device Leader to lead the regulatory strategies for combination products, ensuring compliance and successful approvals across global markets. The role requires extensive expertise in regulatory affairs, particularly related to device and combination products, and emphasizes collaboration across various internal and external stakeholders.

Skills & Requirements

Must-have

  • Global combination product regulations
  • Device & Combination Products
  • Regulatory CMC strategy
  • Health Authority interactions
  • Module 3 sections authoring

Nice-to-have

  • Science-based start-up culture
  • Continuous improvement mindset
  • Cross-functional team leadership
  • External industry forums participation

Key Requirements

  • Master degree or PhD in biotechnology, pharmaceutical sciences, biological science
  • Experience in leadership/management of Regulatory CMC in Device area
  • Deep expertise in global combination product regulations
  • Extensive experience leading combination product strategies and submissions

Work Rights

Not specified

Tailored Resume

Cover Letter