We are currently seeking a Manager Regulatory Reporting & Submissions in our Regulatory Affairs area. The position will use regulatory knowledge to oversee coordination, preparation, and timely submission of high quality documents for regulatory authorities and identify perceived gaps in product development plans that may pose regulatory issues with a focus on the product description/chemistry, manufacturing, & controls (CMC) section.
Altria aspires to be the U.S. leader in authorized, non-combustible, reduced risk products. (Learn more at Altria.com) Our approach to regulatory advocacy relies on deep scientific expertise, understanding of consumers and effective engagement and collaboration with regulatory agencies. Fueled by our strong core tobacco business, we've been concentrating on new product platforms. These include oral nicotine containing products, E-Vapor??, and heated tobacco products.?
We believe these platforms have potential to drive adult smoker conversion. We can only compete in the marketplace with products authorized by the FDA and we can only communicate reduced risk claims with FDA authorization. We plan to file a number of regulatory applications in the coming years.?
As existing products continue to improve, new products become available, and the FDA authorizes manufacturers to communicate accurate risk information, we believe adult smoker conversion will accelerate. This will be a win for adult tobacco consumers, for public health and for our long-term commercial success.
Specific accountabilities include:
Providing regulatory oversight during the coordination and preparation of regulatory submissions focusing on the product description/chemistry, manufacturing, & controls (CMC) section. Working with product development to identify gaps in product development plans that may pose regulatory submission challenges.
Providing regulatory advice to other functional areas and provide regulatory input on change control.
Heading collaborative and cross-functional project teams to execute the product description and chemistry, manufacturing, & controls (CMC) section of pre-market submissions and meet all internal and external deadlines. Providing status updates to management and senior management as appropriate.
Heading and coordinating preparation of responses to queries from regulatory authorities.
Leading technical and management review of regulatory submissions to assure consistent and accurate information.
Master's in engineering or science field including but not limited to Science, Engineering, Operations, Manufacturing, or Product Development. Advanced degree is preferred.
6+ years of experience in FDA regulated industry, contributing to FDA Product Submissions.
Working knowledge of FDA CTP Regulations and Guidance Documents is preferred.
Experience leading, conceiving and completing projects and applications requiring the application of business-specific technical practices, procedures and theories.
In-depth technical scientific/technical/regulatory knowledge and general business acumen.
Proven ability to develop and lead cross-functional and matrix teams to develop and implement project plans; Strong presentation skills to clearly and articulately share project progress and developments.
Strong product management and relationship management skills with proven ability to meet goals and timelines.
Excellent interpersonal/communication skills to interface with management and individuals at all levels of the organization.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Visio) and Adobe Acrobat Professional.
May require occasional domestic and/or international travel Altria Group is a FORTUNE 200 company that owns the premier tobacco companies in the United States including Philip Morris USA, U.S. Smokeless Tobacco Company, John Middleton and Nu Mark. The companies’ brands include Marlboro, Copenhagen, Skoal, Black & Mild, MarkTen and VERVE. Altria also owns Ste. Michelle Wine Estates, one of the country’s top premium wine producers, and Philip Morris Capital Corporation, an investment company. Altria’s mission is to own and develop financially disciplined businesses that are leaders in responsibly providing adult tobacco and wine consumers with superior branded products.
Altria Client Services’ role is to help Altria Group and its operating companies responsibly meet their business goals by providing the high quality services they require in a financially disciplined way. At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development and advancement.
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 incentive compensation and deferred profit sharing programs as well as a relocation assistance package.
Each Altria company is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, disability, gender identity, protected veteran status, or other protected class.