Associate Director Regulatory Affairs - Coe Submission Delivery Team Lead

AstraZeneca

Cambridge, United Kingdom
Competitive salary; excellent compyny benefits; no...
Regulatory submission delivery plans
Lead cross-functional delivery teams
Identify regulatory risks and mitigations
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 requires an inspiring leader who can drive change and motivate teams to achieve exceptional results.
  • 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; Excellent Company Benefits; Not specified

Skills & Requirements

Must-have

  • Regulatory submission delivery plans
  • Lead cross-functional delivery teams
  • Identify regulatory risks and mitigations
  • Experience managing first-wave MAA submissions
  • Strong project management skills

Nice-to-have

  • Inspiring leader
  • Possibility-focused professional
  • Inventive mindset
  • Creative thinker
  • Dynamic learning environment

Key Requirements

  • Relevant University Degree in Science
  • Extensive regulatory experience
  • Thorough knowledge of drug development
  • Proficiency with project management systems
  • Leadership experience
  • Excellent written and verbal communication

Work Rights

Not specified

Tailored Resume

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