International Cmc Regulatory Affairs Associate Director I

Astrazeneca

**
International cmc submissions
Project management expertise
Risk-based regulatory strategies
** AstraZeneca is seeking an International CMC Regulatory Affairs Associate Director I to lead complex regulatory projects and submissions across its product portfolio. The role requires extensive experience in biopharmaceuticals, project management, and regulatory affairs to ensure compliance and timely submission of medicinal products. Candidates are expected to possess strong leadership skills and a deep understanding of global regulatory requirements. **

Job Summary

  • This role leads and manages complex iCMC projects and product ranges across the portfolio, to meet the needs of both AstraZeneca and patients.
  • It combines strong project management with tactical regulatory delivery, ensuring international CMC submissions are planned, coordinated and executed to high standards and agreed timelines.
  • The role partners closely with CMC Product Leads and stakeholders across the organisation to shape and implement innovative, risk-based regulatory strategies.

Matching Summary

Match Score: 75

** AstraZeneca is seeking an International CMC Regulatory Affairs Associate Director I to lead complex regulatory projects and submissions across its product portfolio. The role requires extensive experience in biopharmaceuticals, project management, and regulatory affairs to ensure compliance and timely submission of medicinal products. Candidates are expected to possess strong leadership skills and a deep understanding of global regulatory requirements. **

Skills & Requirements

Must-have

  • International CMC submissions
  • Project management expertise
  • Risk-based regulatory strategies
  • GxP principles application
  • Stakeholder management

Nice-to-have

  • Innovative regulatory strategies
  • Continuous improvement culture
  • Cross-functional collaboration
  • Lean capability
  • Quality Risk Management

Key Requirements

  • University Degree or equivalent
  • Minimum 10 years relevant experience
  • Breadth of knowledge in manufacturing, technical, and regulatory management
  • Strong understanding of global regulatory affairs

Work Rights

Not specified

Tailored Resume

Cover Letter