Regulatory Project Lead

Altria Client Services

Richmond, Virginia

7/3/2020 9:57:18 AM

3370

Legal Regulatory Affairs Regulatory Affairs

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Identify regulatory requirements and lead cross-functional teams toward meeting compliance and regulatory milestones for a Fortune 200 Company with some of the most iconic brands! Have a bachelor’s degree with three years of experience in regulatory, operations, science, business or engineering? Have experience in Project Management? If so, we want to speak with you! We are currently seeking a Project Manager, Regulatory Integration to join our Regulatory Affairs (RA) organization in Richmond, VA.

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 several 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.

This role will assist with compliance and engagement activities for regulatory authorization and U.S. commercialization of potentially reduced risk tobacco products.

Specific accountabilities include:

• Helping identify regulatory requirements and related work streams to prepare for commercialization and post-market requirements

• Leading cross-functional teams and tracking work stream progress toward meeting compliance and regulatory milestones

• Scheduling meetings to inform partners of progress and recording decisions and action items.

• Preparing and delivering presentations to inform others of regulatory requirements, project status, and recaps of actions taken

• Presenting the status of regulatory activities to the commercializing operating company and external contractual partners

• Helping identify regulatory risks and bringing partners together to develop mitigation strategies

• Developing and updating tools for effective management of regulatory activities (shared file space, file structures, dashboards, etc.)

Qualifications include:

• Bachelor’s degree and 3+ years of relevant experience in a science, engineering, operations, regulatory, or business field

• Project management and/or regulatory experience or certification preferred

• Strong interpersonal/communication skills to engage with management and individuals at all levels of the organization

• Proven ability to lead cross-functional and matrix teams to develop and implement project plans

• Working knowledge of FDA processes and CTP regulations and guidance documents preferred

• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Visio)

• Validated ability to meet goals and timelines

• Action orientation to identify and address problems and gaps

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.

Richmond, VA - Virginia



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