Regulatory Affairs Director
AstraZeneca · Gaithersburg, MD
RegulatoryFull-time$186k–$279kCompany career page
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Role summary
AstraZeneca seeks a Regulatory Affairs Director to provide strategic regulatory leadership for infectious disease products across development, commercialization, and lifecycle management. The role involves developing global regulatory strategies, leading cross-functional teams through major submissions, and engaging with health authorities to expedite approvals.
What they're looking for
- Bachelor's degree in life science or related field
- 7+ years regulatory drug development, manufacture, or commercialization experience
- Broad background across multiple regulatory affairs groups or health authority experience
- Knowledge of drug development, marketing approval, and license maintenance procedures
- Proven leadership and project management experience
- Excellent oral, written, and presentation skills
- Ability to work hands-on in fast-paced environments
What you'll be doing
- Develop and implement regional or global regulatory strategy for assigned products
- Lead cross-functional teams through major submissions and health authority interactions
- Deliver regulatory milestones and assess risk, emerging data, and approval probability
- Ensure collaboration across global, regional, and local regulatory affairs functions
- Mentor and provide performance feedback to regulatory staff on assigned projects
Privacy & handoff
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