Manager, Regulatory Project Management
Posted on: 3 Oct 2024
Washington, DC
Job Description
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.
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’:
1. Provides support to US regulatory affairs team
• Serves as backup POC with FDA
• Provides project management skills when other team members need assistance
• Develops templates for use in submission development
• Creates & maintains regulatory submission & correspondence repository
2. Reports timely status of all US regulatory projects
• Maintains & disseminates project summary reports
• Helps draft project reports
• Monitors FDA product decisions, OMB clearance (research, guidances, & rules), & other sources to generate U.S. Regulatory Insights Report
Who we’re looking for:
The person holding this position must have the following qualifications:
• 5 or more years of related public health and industry work experience
• 5 or more years of project management experience in a cross-functional environment
• 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
• Contributed to develop/refinement of IT systems
• Legally authorized to work in the US.
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
Philip Morris International
New York, New York
Philip Morris International Inc. (PMI) is an American multinational cigarette and tobacco manufacturing company, with products sold in over 180 countries outside the United States. The most recognized and best selling product of the company is Marlboro.
Until a spin-off in March 2008, Philip Morris International was an operating company of Altria. Altria explained the spin-off, arguing PMI would have more "freedom" outside the constraints of US corporate ownership in terms of potential litigation and legislative restrictions to "pursue sales growth in emerging markets.", while Altria focuses on the United States. The shareholders in Altria at the time were given shares in PMI, which was listed on the London Stock Exchange and other markets.
The company's headquarters are in New York City. It does not operate in the United States; Philip Morris USA, a subsidiary of PMI's former owner Altria, owns the Philip Morris brands there.
With tobacco being addictive and the single greatest cause of preventable death globally, the company is highly controversial. It has been the subject of litigation and restrictive legislation from governments.
In response to burgeoning awareness of the harm to health of cigarettes, PMI has declared on its homepage the intention to replace cigarettes with smoke-free products, and to "switch ... adult smokers" to these products as the first phase of a business strategy, as a responsible decision for the benefit of "adult smokers" and the companies share-holders and employees.
With the world-wide decrease in smoking in the 21st century, shares of Philip Morris were no longer considered the "safe haven" they once were. The company ranked No. 108 in the 2018 Fortune 500 list of the largest United States corporations by total revenue.
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IndustryTobacco
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No. of Employees77400
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Website
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Jobs Posted14
