Director, Regulatory Affairs Strategy - Cell Therapy
AstraZeneca · Gaithersburg, MD +1 more
RegulatoryFull-time$186k–$279kCompany career page
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Role summary
AstraZeneca seeks a Director of Regulatory Affairs Strategy for cell therapy programs spanning oncology, immune-mediated, and rare diseases. This role shapes global regulatory pathways from expedited designations through submissions and post-approval activities, partnering with cross-functional teams to deliver transformative therapies.
What they're looking for
- Bachelor's degree in science-related field
- 5+ years regulatory experience, preferably in cell therapy
- Understanding of global regulatory science integrated with program strategy
- Experience leading complex or novel biologic development programs
- Proven track record managing regulatory teams and cross-functional stakeholders
- Leadership of Health Authority interactions in major markets
- Strong strategic thinking, risk assessment, and communication abilities
What you'll be doing
- Develop and implement global regulatory strategy for cell therapy products through submission milestones and maintenance activities
- Lead regulatory strategy and execution for Health Authority meetings, information requests, expedited pathway designations, and BLA submissions
- Assess emerging data objectively and communicate program risks and mitigation strategies to senior leadership
- Lead preparation of regulatory strategy documents, target product labeling, and support global dossier assembly
- Mentor less experienced colleagues and contribute to process improvements across regulatory functions
Privacy & handoff
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