Sr Manager Regulatory Submissions
About The Position
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.
Requirements
- 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
Responsibilities
- 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
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
