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Director, Regulatory Compliance
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Full-time
- We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups.
- We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside.
- The Regulatory Affairs department plays a critical role in ensuring that our products meet regulatory standards and compliance requirements to deliver safe and effective gene therapy solutions to patients.
- Together, these departments collaborate closely to navigate the complex regulatory landscape, drive continuous improvement, and uphold the highest standards of quality and compliance in support of our mission to enable access to life changing gene therapy solutions for our patients.
- The Regulatory Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the CDMO business unit.
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