Senior
Senior Regulatory Scientist, Data Integrity
Manage reporting processes for analytical data intended for regulatory applications of potential reduced risk products for a fortune 500 company with some of the most iconic brands! Have a degree in data analytics, chemistry, life science, physical science, engineering, or a related field? Have experience in analytical chemistry, research, or product development in a regulatory environment? If so, we want to speak with you!
We are actively recruiting a Senior Regulatory Scientist, Data Integrity, to join our team in Richmond, VA.
The Senior Regulatory Scientist role will independently develop, manage, and apply in-depth data analytics and integrity knowledge along with regulatory and scientific knowledge. The individual will be required to provide deconvoluted analytical data to guide regulatory strategy teams across various new product platforms in their reporting processes intended for regulatory submissions (e.g., PMTAs). The role will be expected to collaboratively integrate data analytics knowledge with regulatory strategies and timelines across the Regulatory Sciences department and regulatory submissions teams. They will also proactively conceive of and formulate data infrastructure improvement opportunities from internal and external data sources in support of regulatory submissions.
What you’ll be doing:
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Coordinate the data generation and reporting workflows for testing intended for FDA regulatory submissions.
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Develop and manage quality-compliant analytical data infrastructure intended for FDA regulatory submissions, including content, format and integrity of data from internal/external laboratories.
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Maintain strong working knowledge of FDA data regulations, including CDISC-TIG, guidance documents and reporting requirements for regulatory submissions.
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Liaison to LIMS and Sample-Data Management teams for implementation of reporting for all platforms supported by regulated laboratory testing.
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Collaborate with colleagues during planning meetings regarding project timelines and project-related issues focusing on capabilities within, but not limited to, Data Management, Logistics, and Laboratory Testing.
What we want you to have:
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Bachelor’s degree in chemistry, life science, physical science, engineering, or in a related field; Advanced degree preferred
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5+ years of relevant experience in a regulated laboratory or agency, with preferred prior experience with tobacco product regulatory submissions, laboratory data management, data analytics/integrity, data engineering and design related to analytical chemistry or research environments
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Knowledge of various Data Analytics, Data Engineering and Design approaches
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Strong project management skills with the ability to balance priorities in a deadline-oriented environment
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Proficiency with Microsoft Office applications and widely used tools and technology such as Python, SQL, Power BI or other data analytics tools
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Prefer core understanding of laboratory techniques and applications (chromatographic and spectroscopic), including experience with method development and validation
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