Director, Regulatory Cmc Device Leader

argenx.uk

Onsite
Global combination product regulations
Combination product strategies and submissions
Device related module 3 sections
Argent is seeking a Director, Regulatory CMC Device Leader to lead the regulatory strategy for combination products in immunology. The ideal candidate should possess deep expertise in global combination product regulations and demonstrate strong leadership in a dynamic environment

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.

Matching Summary

Match Score: 85

Argent is seeking a Director, Regulatory CMC Device Leader to lead the regulatory strategy for combination products in immunology. The ideal candidate should possess deep expertise in global combination product regulations and demonstrate strong leadership in a dynamic environment.

Skills & Requirements

Must-have

  • global combination product regulations
  • combination product strategies and submissions
  • device related Module 3 sections
  • design control, risk management, human factor studies
  • cross-functional team leadership
  • regulatory CMC strategy for combination products

Nice-to-have

  • science-based start-up culture
  • continuous improvement mindset
  • external industry forums participation

Key Requirements

  • Master degree or PhD in biotechnology, pharmaceutical sciences, biological science
  • Experience in leadership/management of Regulatory CMC in the Device area
  • Relevant expertise in CMC and Device & Combination products

Work Rights

Not specified

Tailored Resume

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