Associate Director Regulatory Affairs - Coe Submission Delivery Team Lead

AstraZeneca

Cambridge, UK
Regulatory submission project management
Leading cross-functional teams
Marketing authorisation application submissions
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide by working entrepreneurially, thinking big, and collaborating to make the impossible a reality

Job Summary

  • At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide by working entrepreneurially, thinking big, and collaborating to make the impossible a reality.
  • The Associate Regulatory Affairs Director leads cross-functional teams to deliver complex global regulatory submissions, driving transformational change and fostering a dynamic learning environment.
  • The role offers a competitive salary, excellent company benefits, and a flexible office working model balancing in-person collaboration with individual flexibility.

Matching Summary

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide by working entrepreneurially, thinking big, and collaborating to make the impossible a reality.

Skills & Requirements

Must-have

  • Regulatory submission project management
  • Leading cross-functional teams
  • Marketing Authorisation Application submissions
  • Oncology therapeutic area expertise
  • Regulatory risk identification and mitigation
  • Use of project management software
  • Driving transformational change

Nice-to-have

  • Creative problem solving
  • Coaching and capability building
  • Cultural awareness
  • Collaborative leadership style
  • Experience with lifecycle management
  • Knowledge of AstraZeneca processes
  • Supporting acceleration initiatives

Key Requirements

  • Relevant University Degree in Science or related discipline
  • Extensive regulatory experience in biopharmaceutical industry or health authority
  • Strong project management skills
  • Experience leading multi-disciplinary project teams as SDTL or similar
  • Experience managing first-wave Marketing Application submissions
  • Excellent written and verbal communication skills

Work Rights

Not specified

Tailored Resume

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