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Sr Manager Regulatory Submissions

Philip Morris International U.S. -
Washington, DC

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Job Details

Full-time
$176,000 - $220,000 a year

Benefits

Commuter assistance
Health insurance
Dental insurance
Paid time off
Vision insurance
401(k) matching
Pet insurance

Qualifications

Editorial project management
FDA submissions
Medical writing
Content writing
Compliance documentation

Full 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.

The role entails leading the planning, authorship, and editorial quality of high‑stakes regulatory documents to support U.S. tobacco/nicotine product submissions and lifecycle obligations, ensuring clear, accurate, and compliant communication with the FDA and other external stakeholders. Driving writing standards, document governance, and cross‑functional collaboration across PMI US and PMI Global.

Your ‘day to day’:
*

Authoring Regulatory Documents
Drafting and formatting complex FDA submissions (e.g., PMTA/MRTPAs, amendments, supplements, and postmarket reports) as well as responses to FDA Information Requests and Deficiency Letters, sometimes under tight timelines

Creating supporting documents within submissions and ensuring scientific accuracy, internal consistency, and traceability to source data
Aligning all documents with FDA law, regulations, and guidance documents
Maintaining consistency with internal company policies

Narrative Development & Data Integration
Synthesizing complex scientific data into cohesive narratives that support regulatory strategy & product authorization
Identifying data and information needed to support regulatory submissions, including types of studies, study designs, and data analysis, in collaboration with scientific SMEs
Strategic Development & Implementation
Identifying regulatory strategy and tactics to allow marketing of PMI products
Identify complex, time-sensitive issues that prevent risk to submission readiness in a timely manner and facilitate resolution of issues
Acting as regulatory SMEs, representing the US Regulatory Affairs Team in cross-functional project teams and ensuring alignment across PMI with evolving regulatory landscape

Who we’re looking for:

Minimum 8 years of experience in regulatory affairs for tobacco, pharmaceuticals or other FDA‑regulated products
Minimum 5 years of regulatory/scientific writing or evaluation of FDA applications for tobacco products
Extensive experience and leading role in regulatory writing projects (e.g., multi‑module submissions, iterative engagement between FDA and applicants, cross‑functional content integration)
Extensive knowledge and understanding of FDA’s regulatory requirements for tobacco product submissions
Experience in leading regulatory writing
Mastery of regulatory document structures for FDA premarket applications and postmarket reporting as well as in-depth knowledge of FDA/CTP processes
Editorial excellence (structure, argumentation, data display, reference management) and plain‑language communication
Advanced degree in a scientific discipline (e.g., PhD/ScD, PharmD, MS/MPH) or equivalent

Annual Base Salary Range: $176,000-$220,000

#LI-Hybrid #LI-JW1

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 millions of smokers.

PMI is an Equal Opportunity Employer.

PMI is headquartered in Stamford, Conn., and its U.S. affiliates have more than 2,300 employees.

PMI has been an entirely separate company from Altria and Philip Morris USA since 2008. PMI’s affiliates first entered the U.S. market following the company’s acquisition of Swedish Match in late 2022. Philip Morris International and its U.S. affiliates are working to deliver a smoke-free future. Since 2008, PMI has invested $12.5 billion globally to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke with the goal of transitioning legal-age consumers who smoke to better alternatives. In 2022, PMI acquired Swedish Match – a leader in oral nicotine delivery – creating a global smoke-free champion led by the IQOS and ZYN brands. The U.S. Food and Drug Administration has authorized versions of PMI’s IQOS electronically heated tobacco devices and Swedish Match’s General snus as Modified Risk Tobacco Products and renewal applications for these products are presently pending before the FDA. For more information, please visit www.pmi.com/us and www.pmiscience.com. #INDPMI

Work Location: In person

Apply Now

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