Associate Director Regulatory Affairs - Coe Submission Delivery Team Lead

AstraZeneca

Cambridge, UK
Regulatory submission management
Project management skills
Leadership of cross-functional teams
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide by working entrepreneurially and collaboratively 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 and collaboratively to make the impossible a reality.
  • The role involves leading complex global regulatory submissions for a healthy oncology portfolio and driving transformational change through innovative strategies and team motivation.
  • The company offers competitive salary, excellent benefits, and a flexible office working environment balancing in-person collaboration and individual flexibility.

Matching Summary

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

Skills & Requirements

Must-have

  • Regulatory submission management
  • Project management skills
  • Leadership of cross-functional teams
  • Oncology regulatory expertise
  • Marketing Authorisation Application submissions
  • Regulatory risk identification and mitigation
  • Proficiency with project management tools

Nice-to-have

  • Creative problem solving
  • Driving transformational change
  • Coaching and mentoring skills
  • Cultural awareness
  • Collaborative team environment
  • Innovative solution development

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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