Senior Regulatory Scientist, Data Integrity

Altria Client Services LLC in; Richmond (VA); Hybrid; USD 105,000 - 152,000; Full time

Benefits offered by this job

Flexible remote options

Paid time off and holidays

401(k) matching and profit sharing

Job summary

Altria is seeking a Senior Regulatory Scientist, Data Integrity (Finance) to lead data analytics and integrity efforts for regulatory submissions in Richmond, VA. You will develop data infrastructure, ensure regulatory compliance, and collaborate with Regulatory Sciences and submissions teams.

The role requires a strong background in analytical data, regulatory knowledge, and laboratory data management, with candidate comfort in cross-functional planning and data governance.

Qualifications

• Bachelor's degree in chemistry, life science, physical science, or engineering; advanced degree preferred.
• 5+ years in a regulated laboratory or agency with regulatory submissions experience.
• Knowledge of data analytics, data engineering and design approaches for regulated data.
• Strong project management skills in deadline-driven environments.
• Proficiency with Python, SQL, Power BI and MS Office.
• Understanding of laboratory techniques and validation processes.

Responsibilities

• Coordinate data generation and reporting workflows for FDA submissions.
• Develop and manage quality analytical data infrastructure for regulatory submissions.
• Maintain knowledge of FDA data regulations and CDISC-TIG guidance.
• Liaise with LIMS and Sample-Data Management teams on reporting.
• Collaborate cross-functionally to align data analytics with regulatory timelines.

Skills

Data analytics

Regulatory knowledge

Project management

Communication

Python

SQL

Power BI

Education

Bachelor's degree in chemistry, life science, physical science, or engineering

Advanced degree preferred

Tools

LIMS

Microsoft Office

Job description

Senior Regulatory Scientist, Data Integrity (Finance)

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.