Manager Regulatory Submissions

Overview Lead efforts for submission of premarket new product applications in compliance with FDA requirements for a fortune 200 company with some of the most iconic brands! Have a bachelor’s degree with experience in FDA regulated fields and working knowledge of FDA CTP requirements? If so, we want to speak with you! We are currently seeking a Manager Regulatory Submissions to join our team in Richmond, VA. or we are open to remote work arrangements. This person will use regulatory knowledge and problem-solving skills to assure the accurate and efficient compilation, analysis, and summation of complex information for submission to FDA. In this role, you will: • Lead cross-functional efforts to satisfy FDA regulatory requirements including pre-market submissions using regulatory knowledge, understanding of science, and problem-solving skills to assure the accurate and efficient compilation, analysis, and summation of complex information • Collect, analyze, and summarize information to be submitted on behalf of Altria Operating Companies to comply with federal regulatory requirements, including FDA requirements • Collaborate with cross-functional partners and study leads to develop premarket application narratives and lead the application review process, QC, and publishing. • Lead efforts to respond to FDA inquiries and review questions related to product submissions • Manage the full review of regulatory submissions to assure consistent and accurate information • Represent Regulatory Affairs in the Product Change Management process. • Lead large-scale projects to complete pre-market submissions and meet external deadlines We want you to have: • Bachelor’s degree in Science, Engineering, Operations, Business, or a related field. Advanced degree is preferred. • 5 - 7+ years of relevant work experience with 3+ years in FDA regulated fields and working knowledge of FDA CTP Requirements and Guidance Documents • Prior experience leading FDA product submissions for a regulated company. • Strong understanding of and demonstrated experience in Project Management processes • Strong research, data analysis and interpretation skills and experience, ideally applied in a regulatory environment • Demonstrated ability to understand and apply scientific principles in a regulated industry • Strong ability to synthesize large amounts of data and ensure accuracy in regulatory reporting • Proficiency in Microsoft Project Professional, Microsoft Office Suite (Excel, Word, PowerPoint, Visio), and Adobe Acrobat Professional. • Strong Leadership and relationship management skills with proven ability to meet goals and timelines. • Strong interpersonal/communication skills to collaborate with management and individuals at all levels of the organization. In addition to the opportunity to apply and develop your skills toward key 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. Company Overview Altria has a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. Altria’s Vision through 2030 is to responsibly lead the transition of adult smokers to a non-combustible future. Altria is Moving Beyond Smoking™, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices - believing it is a substantial opportunity for adult tobacco consumers, Altria’s businesses and society. Altria’s wholly owned subsidiaries include the most profitable tobacco companies in their categories: Philip Morris USA Inc. (PM USA), U.S. Smokeless Tobacco Company LLC (USSTC), and John Middleton Co. (Middleton). Altria’s smoke-free portfolio includes Helix Innovations LLC (Helix), the maker of on! oral nicotine pouches, exclusive U.S. commercialization rights to the IQOS Tobacco Heating System®* and Marlboro HeatSticks®*, and an equity investment in JUUL Labs, Inc. (JUUL). Altria also owns equity investments in Anheuser-Busch InBev SA/NV (ABI), the world’s largest brewer, and Cronos Group Inc. (Cronos), a leading Canadian cannabinoid company. At Altria, we celebrate the power of diverse teams working together to shape our future. We are inspired to bring our best because our unique strengths are valued. We believe our personal success and progress should be guided by Our Cultural Aspiration, a new articulation of what we value and who we aspire to be, collectively. Our Cultural Aspiration respects and complements individual identity, embracing each other’s unique strengths, welcoming newcomers and developing the best, most inclusive and diverse teams. Join us as we work together to shape a better future for adult tobacco consumers, our employees, and our shareholders. Each Altria company is an equal opportunity employer. Learn more about Altria at www.altria.com and follow us on Twitter, Facebook and LinkedIn. *IQOS Devices and HeatSticks® are currently unavailable for sale in the United States.