Regulatory Affairs Strategy Director
$186,233–$279,349 year
On-siteBoston, Massachusetts, United States
Job Summary
Lead global regulatory strategy and operational execution for assigned products within Cardiovascular, Renal or Metabolism, serving as the global or regional regulatory lead on specific indications. Define and implement regulatory strategies for therapeutic assets while engaging Health Authorities to influence development programs and improve outcomes. Manage the full lifecycle of drug development, from early to late stages, ensuring successful product approval and launch across diverse small and big molecule pipelines. Collaborate cross-functionally to transform scientific capabilities into valued new medicines, driving innovation within AstraZeneca's growing pipeline.
Required Qualifications
- Advanced Degree in Life Science or related discipline
- 5+ years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization
- Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development
- Proven track record of regulatory drug development including product approval/launch
- Experience in leading Major Health Authority interactions
- Ability to think strategically and critically and evaluate risks to regulatory activities
- Ability to work strategically within a complex, business critical and high-profile development program
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