International Cmc Regulatory Affairs Associate Director I

AstraZeneca

10 years biopharmaceutical industry experience
Global regulatory affairs knowledge
Project management for icmc submissions
This role leads complex international CMC projects to ensure timely regulatory submissions and approvals across the product lifecycle

Job Summary

  • This role leads complex international CMC projects to ensure timely regulatory submissions and approvals across the product lifecycle.
  • The position requires managing cross-functional teams and applying robust risk management strategies to balance speed with quality and compliance.
  • Candidates will foster a learning culture while ensuring adherence to AstraZeneca values, ethics, and global regulatory standards.

Matching Summary

This role leads complex international CMC projects to ensure timely regulatory submissions and approvals across the product lifecycle.

Skills & Requirements

Must-have

  • 10 years biopharmaceutical industry experience
  • Global regulatory affairs knowledge
  • Project management for iCMC submissions
  • Stakeholder and team leadership skills
  • GxP principles application

Nice-to-have

  • Experience with monoclonal antibodies
  • Lean capability in regulatory processes
  • Quality Risk Management expertise
  • Resource management for pivotal projects
  • Continuous improvement culture mindset

Key Requirements

  • University degree in science or technical field
  • Minimum 10 years relevant industry experience
  • Proven ability to lead teams of 3-5 members

Work Rights

Not specified

Tailored Resume

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