Senior Regulatory Scientist, Data Integrity

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Job Title: Senior Regulatory Scientist, Data Integrity

Req Id: 3105

Work Model: Hybrid

Company: Altria Client Services

State/Province: Virginia

Job Description:

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:

• Coordinate the data generation and reporting workflows for testing intended for FDA regulatory submissions.
• Develop and manage quality-compliant analytical data infrastructure intended for FDA regulatory submissions, including content, format and integrity of data from internal/external laboratories.
• Maintain strong working knowledge of FDA data regulations, including CDISC-TIG, guidance documents and reporting requirements for regulatory submissions.
• Liaison to LIMS and Sample-Data Management teams for implementation of reporting for all platforms supported by regulated laboratory testing.
• 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:

• Bachelor's degree in chemistry, life science, physical science, engineering, or in a related field; Advanced degree preferred
• 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
• Knowledge of various Data Analytics, Data Engineering and Design approaches
• Strong project management skills with the ability to balance priorities in a deadline-oriented environment
• Proficiency with Microsoft Office applications and widely used tools and technology such as Python, SQL, Power BI or other data analytics tools
• Prefer core understanding of laboratory techniques and applications (chromatographic and spectroscopic), including experience with method development and validation

The starting salary is based on but not limited to experience, knowledge, and qualifications in determining compensation decisions. The Salary Range for this position is: $104,900.00 - $152,150.00.

Why You'll Love Building Your Career at Altria

At Altria, we believe a great career starts with feeling supported - both at work and in life. Here's what you'll find here:

• Work where life works for you - with flexible and remote options that fit your world, not the other way around.
• Own your time - start with 15 days of paid time off, 13 paid holidays, 2 floating holiday days, and a 37.5-hour workweek so you can recharge and live fully
• A place where you belong - where your ideas are welcomed, your growth is encouraged, and your impact is real
• Get recognized for your work - annual merit increases and performance bonus
• A future you can count on - 401(k) matching from day one; plus Deferred Profit Sharing, an annual company contribution in an amount equal to 13%-17% of your base salary
• Help with your goals - get help with student loan repayment assistance, attend a conference, or gain a new certification with professional development stipends
• Support for what matters most - comprehensive medical, dental, and vision coverage for you and your family
• Celebrating your milestones - paid parental and bonding leave for life's biggest moments.
• Wellness that goes beyond work - programs that care for your whole well-being at whatever stage you are in your life
• A culture that gives back - paid volunteer days and a shared commitment to making a difference

At Altria, we offer more than benefits - we offer a career that fits your life, rewards your ambition, and celebrates your impact.

This position is not eligible for sponsorship.

Altria is a Fortune 500 company that has a leading portfolio of products for U.S. adult tobacco and nicotine consumers 21+. For decades we've been leaders in the tobacco industry, but the industry is evolving - and so are we. Our Vision is Moving Beyond Smoking.

At Altria, we celebrate the power of diverse teams working together to shape our future. Each Altria company is an equal opportunity employer. We are committed to providing individuals with criminal records, including formerly incarcerated individuals and individuals with conviction records, a fair chance at employment. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders.

Altria is the parent company of Philip Morris USA, John Middleton, U.S. Smokeless Tobacco, Helix Innovations, and NJOY. Altria complements its tobacco portfolio with equity investments in Anheuser-Busch InBev and Cronos Group.

Learn more about Altria at www.altria.com and follow us on LinkedIn.

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