Associate Director Regulatory Affairs - Coe Submission Delivery Team Lead

AstraZeneca

Cambridge, United Kingdom
Competitive salary; excellent compyny benefits; no...
Regulatory project management
Marketing authorisation applications
Clinical line extension submissions
The Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL) is responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions

Job Summary

  • The Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL) is responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions.
  • This role requires an inspiring leader who can drive change and motivate teams to achieve exceptional results, identifying regulatory risks and communicating mitigations to stakeholders.
  • Partnering with the Global Regulatory Lead (GRL), you will be leading cross-functional delivery teams for the planning, preparation, and delivery of complex MAA and/or CLE submissions.

Matching Summary

The Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL) is responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions.

Salary

Competitive Salary; Excellent Company Benefits; Not specified

Skills & Requirements

Must-have

  • Regulatory project management
  • Marketing Authorisation Applications
  • Clinical Line Extension submissions
  • Oncology portfolio
  • Cross-functional team leadership
  • Regulatory risk identification and mitigation

Nice-to-have

  • Entrepreneurial and possibility-focused
  • Inspiring leader
  • Creative thinking for innovative solutions
  • Continuous improvement mindset
  • Adapt to new technologies

Key Requirements

  • Relevant University Degree in Science
  • Extensive regulatory experience
  • Strong project management skills
  • Leadership experience
  • Experience managing first-wave Marketing Application submissions

Work Rights

Not specified

Tailored Resume

Cover Letter