Senior Regulatory Scientist
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Coordinate analytical data intended for regulatory applications of potential reduced risk products for a fortune 200 company with some of the most iconic brands! Have a bachelor s degree in 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 to join our team in Richmond, VA. or we are open to remote work arrangements.
The Senior Regulatory Scientist will independently apply scientific knowledge to interpret and deconvolute analytical data, to facilitate decision-making by regulatory strategy and product development teams. They will also be expected to collaborate across the Analytical Sciences department and related product development and regulatory teams to identify quality improvement opportunities, while staying informed on developing strategies for regulatory submission.
What you ll be doing:
Coordinate the data generation and reporting workflows for the New Product Assessment (NPA) group for product development and testing intended for FDA regulatory submissions
Lead quality review activities for analytical data, including data integrity, format, and content in compliance with Analytical Sciences quality procedures and FDA submission requirements.
Serve as principal resource in NPA group for managing analytical data including collaboration and updates via summarized data and metrics to key partners
Develop and maintain strong working knowledge of FDA regulatory reporting requirements for potential reduced risk products
Maintain and manage the appropriate documentation for Analytical Sciences to be aligned with Altria Quality Systems and Records Management policies
What we want you to have:
Bachelor s degree in chemistry, life science, physical science, engineering or in a related field, Advanced degree preferred
5+ years of relevant laboratory experience in a regulated environment, preferred prior experience in analytical chemistry, research or product development in a tobacco-regulated environment or regulatory agency
Strong research, data analysis and data interpretation skills
Ability to develop and implement new solutions in a regulated environment
Working knowledge of laboratory techniques and applications to include chromatographic and spectroscopic analytical methods, including experience with method development and validation
Experience working in an ISO 17025 Accredited laboratory or other regulated laboratory environment is helpful
Strong communication skills and experience including development and delivery of communication documents and protocols
Strong project management skills with the ability to balance priorities in a deadline-oriented environment
Proficiency with Microsoft Office applications and basic statistics
In addition to the growth opportunity to expand your expertise toward business objectives, we offer an excellent compensation package including a competitive base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation assistance package.