Identify regulatory risks and communicate mitigations
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide
Job Summary
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide.
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.
We balance the expectation of being in the office while respecting individual flexibility.
Matching Summary
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide.
Salary
Competitive Salary; Excellent Company Benefits; Not specified
Skills & Requirements
Must-have
Submission delivery plans and best practices
Lead cross-functional delivery teams
Identify regulatory risks and communicate mitigations
Regulatory submission-related experience
Strong project management skills
Experience leading multi-disciplinary project teams
Nice-to-have
Inspiring leader who can drive change
Possibility-focused professional
Inventive mindset to develop ideas
Creative thinker who can develop innovative strategies
Entrepreneurial, thinking big, and working together
Key Requirements
Relevant University Degree in Science or related discipline
Extensive regulatory experience within the biopharmaceutical industry
Thorough knowledge of drug development
Proficiency with common project management and document management systems
Experience in managing first-wave Marketing Application submissions