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Regulatory Affairs Diagnostic Strategy Lead
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- Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.
- The Regulatory Diagnostic Lead will be the regulatory diagnostic subject matter expert at Spark and will work to lead and deliver on global diagnostic regulatory strategy as an integrated part of the global regulatory strategy for the Gene Therapy.
- This role is responsible for leading/managing global regulatory plans to support a precision medicine approach (e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.
- The Regulatory Diagnostic Lead will also be responsible for recommending strategies for earliest possible approvals of diagnostics and devices in support of clinical trials and marketing authorization applications, and will combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured and/or distributed to meet the required legislation in the target market.
- Familiarity with gene therapy is desirable.
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