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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
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PharmaDx Director, Quality and Regulatory Affairs
The PharmaDx Director, Quality and Regulatory Affairs is responsible for developing and implementing the quality and regulatory strategies for the PharmaDx Department. The PharmaDx Director, Quality and Regulatory Affairs supports the establishment and execution of sustainable processes, assures informed relationships with internal and external stakeholders, and delivers strategic outcomes in the areas of quality and regulatory affairs. Acts as the liaison with external regulatory colleagues and provides regulatory guidance to ensure achievement of strategic goals. Provides critical guidance for change management and audit processes for PharmaDx projects. This position is also responsible for ensuring ongoing compliance to applicable regulations and standards (e.g.: ISO, FDA, IVD
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