Sr Manager, US Regulatory Submissions

Be a part of a revolutionary change

At PMI, we’ve chosen to do something incredible. We’re totally transforming our business and building our future on one clear purpose – to deliver a smoke-free future.

In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. We can now provide legal age nicotine users who would otherwise continue to smoke, access to a broader range of better alternatives to combustible products.

With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.

Our success depends on people who are committed to our purpose and have an appetite for progress.

Your ‘day To Day’

• Manages regulatory submission development & assembly
• Coordinates communication across multifunctional submission preparation teams to ensure that all parties are aligned
• Manages project timeline, include tasks, responsible parties, and target completion dates
• Identifies any issues that present risk to submission readiness in a timely manner and facilitates resolution of issues by appropriate parties
• Manages TPSAC preparation activities
• Develops documentation of steps to assemble marketing applications & other FDA submissions and identifies changes to streamline & expedite the process
• Serve as key writer for regulatory submissions
• Identifies opportunities to create submissions likely to receive FDA authorization
• Helps develop framing of submissions narratives (storyboards)
• Serves as the primary author for drafting submission executive summaries
• Helps to ensure that each module is written such that the full assembled submission is integrated to support the narrative
• Monitors & facilitates internal & external activities related to regulatory submissions
• Monitors research being conducted for regulatory submissions
• Identifies any issues with research that may negatively impact regulatory submission content and timeline
• Liaises with US Commercial to ensure regulatory needs are being met
• Networks with external stakeholders interested in regulatory submissions
  
  

Who We’re Looking For

• Advanced degree in a scientific or medical field
• 5 or more years of related public health and industry work experience
• Knowledge of tobacco science
• Ability to collaborate cross-functionally in a matrixed organization
• Demonstrated ability to influence peers and organizational leadership on significant policy decisions
• Experience communicating orally and in writing to a variety of audiences (e.g., scientists, clinicians, lawyers, government officials, and businesspersons)
• Reputation for ethical conduct and unquestionable integrity
• Strong interpersonal and networking skills
• Demonstrated creative and strategic thinking
  
  

It is preferred that the person holding this position have the following qualifications:

• 3 or more years of experience at FDA’s Center for Tobacco Products
• 3 or more years of experience at tobacco manufacturer or related organization
• Thorough understanding of FDA regulatory processes for tobacco products
• Relationships with a wide range of stakeholders at tobacco government agencies, NGOs, and product manufacturers
  
  

What we offer

• We offer a competitive base salary, annual bonus (applicable based on level of position), great medical, dental and vision coverage, 401k with a generous company match, incredible wellness benefits, commuter benefits, pet insurance, generous PTO, and much more!
• We have implemented Smart Work, a hybrid model of working that promotes flexibility in the workplace.
• Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore.
• Be part of an inclusive, diverse culture where everyone’s contribution is respected; Collaborate with some of the world’s best people and feel like you belong.
• Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress.
• Take pride in delivering our promise to society: To improve the lives of a billion smokers.
  
  

Annual Base Salary Range: $154,500-$206,000

PMI is an Equal Opportunity Employer

PMI Global Services Inc. and PM Global Brands Inc. are a subsidiary of Philip Morris International Inc. Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, its shareholders and its other stakeholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products, associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group, Inc. for sale under license in the U.S., where these products have received marketing authorizations from the U.S. Food and Drug Administration (FDA) under the premarket tobacco product application (PMTA) pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a Modified Risk Tobacco Product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI's smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of September 30, 2023, PMI's smoke-free products are available for sale in 82 markets in key cities or nationwide, and PMI estimates that approximately 19.7 million adults around the world, excluding Russia and Ukraine have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.

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