Regulatory Project Manager, Associate Manager

Altria Client Services

Richmond, Virginia

6/24/2020 11:41:18 AM

3371

Legal Regulatory Affairs Regulatory Affairs

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Provide planning and project management services on a high-achieving team responsible for the support of successful regulatory submissions for a Fortune 200 Company with some of the most iconic brands! Have a bachelor’s degree with eight years of professional experience? Do you have experience working in a FDA regulated field? If so, we want to speak with you! We are currently seeking a Regulatory Project Manager, Associate Manager to join our Regulatory Affairs (RA) organization in Richmond, VA.

Our 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. (Learn more at Altria.com) Fueled by our strong core tobacco businesses, we are investing in new, non-combustible platforms like oral nicotine, e-vapor, and heated tobacco products. As these 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.

Achieving our 10-year vision requires numerous regulatory submissions. And, our approach to these submissions relies on deep scientific expertise, an understanding of consumers and effective engagement and collaboration with regulatory agencies.

Specific accountabilities include:

• Collaborating with cross-functional groups to develop the work-streams, project plans, budgets and target completion dates necessary for successful regulatory submissions.

• Presenting summaries of project milestones, progress and emerging issues to RA management, and supporting them in preparation of presentations to Project Governance Boards.

• Setting up and directing regular interdepartmental meetings and weekly work-stream meetings to facilitate communication across departments and to monitor project execution. Participating in regular meetings with vendors to monitor project execution activities for outsourced project work.

• Documenting outcomes of project-related discussions by generating meeting minutes, action items, and decision logs. Creating and updating shared file space for projects to serve as a repository for project-related documents.

• Identifying and presenting high level project risks and developing risk mitigation strategies and alternative scenario plans. Facilitating and documenting lessons learned discussions throughout project execution.

Qualifications include:

• Bachelor’s degree or equivalent experience in a Science, Engineering, Operations, or Business Discipline. Advanced degree is preferred.

• 8+ years of experience with 3+ years in a FDA regulated field.

• Working knowledge of FDA, Center for Tobacco Products Regulations and Guidance Documents preferred.

• Prior experience with FDA product submissions and scientific study execution for a regulated company preferred.

• Previous experience managing budgets and vendors.

• Strong understanding of Project Management processes - Project Management Professional (PMP) certification preferred.

• 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 communication skills to collaborate 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.

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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