Manager-US Regulatory Oversight & Insights

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 Annual Base Salary Range: $144,000 - $198,000 #LI-Hybrid 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. 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, 2022, PMI's smoke-free products are available for sale in 70 markets in key cities or nationwide, and PMI estimates that approximately 13.5 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. Philip Morris International is committed to a safe workplace. We have implemented COVID-19 safety protocols that meet or exceed local public health guidelines. Workplace safety remains our number one priority. As a result, PMI recommends all US- and Canada-based employees to be vaccinated in order to access any of our facilities; this is subject to change solely at the Company’s discretion.