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Master scientist - regulatory submissions - (Winston-Salem, NC)

Responsibilities: Lead key work streams critical to the development of Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for submission to FDA Establish relationships and partner with both internal and external stakeholders across a broad set of disciplines and contexts (eg Product Integrity, Product Development, Consumer Marketing, Product Services, Manufacturing Operations, Contract Service Providers, Contract Research Organizations) Contribute to the development of research strategies that support regulatory submissions Develop, refine, and ultimately drive tactical plans to support regulatory submissions and objectives Contribute to and communicate strategic and operational regulatory guidance and ability to internal stakeholders in a manner consistent with the operating company's objectives Lead the assembly of PMTAs/MRTPAs and work with stakeholders to ensure the creation, review


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Posted in Winston-Salem, NC, Science & Research
From Jobs-Search - 1 month ago