Associate Director Regulatory Affairs - Coe Submission Delivery Team Lead

AstraZeneca

Cambridge, United Kingdom
Competitive salary; bonus/equity: excellent compyn...
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 an experienced regulatory specialist with strong project management abilities, responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions to support a very healthy oncology portfolio

Job Summary

  • The Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL) is an experienced regulatory specialist with strong project management abilities, responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions to support a very healthy oncology portfolio.
  • This role sits in the CoE SDTL SME team within the SDTL pillar of the CoE.
  • We balance the expectation of being in the office while respecting individual flexibility.

Matching Summary

The Associate Regulatory Affairs Director - Centre of Excellence (CoE) Submission Delivery Team Lead (SDTL) is an experienced regulatory specialist with strong project management abilities, responsible for leading Marketing Authorisation Application (MAA) and Clinical Line Extension (CLE) cross-functional submission teams to deliver global submissions to support a very healthy oncology portfolio.

Salary

Competitive Salary; Bonus/Equity: Excellent Company Benefits; Benefits: Excellent Company Benefits

Skills & Requirements

Must-have

  • Regulatory project management
  • Marketing Authorisation Applications
  • Clinical Line Extension submissions
  • Cross-functional team leadership
  • Regulatory risk identification and mitigation
  • Submission delivery plans and best practices

Nice-to-have

  • Entrepreneurial and possibility-focused
  • Inspiring leader and change driver
  • Creative thinking for innovative solutions
  • Coaching and upskilling capabilities
  • Influencing internal processes

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter