Sr Manager Regulatory Submissions

Be a Part of a Revolutionary Change At PMI, we’re transforming our business and building a smoke‑free future. This transformation creates exciting opportunities for talented professionals to make an impact, drive innovation, and grow their careers. Our success depends on people who are committed to our purpose and have an appetite for progress. Your Impact As a Senior Regulatory Writing Lead, you will lead the planning, development, and quality of high-priority regulatory documents supporting U.S. tobacco and nicotine product submissions and lifecycle obligations. You will ensure clear, accurate, and compliant communication with the FDA while partnering across PMI US and Global teams. Key Responsibilities Regulatory Document Authoring Author and manage FDA submissions, including PMTAs, MRTPAs, amendments, supplements, post-market reports, and responses to FDA requests. Prepare supporting regulatory documentation while ensuring scientific accuracy, consistency, and traceability. Ensure compliance with applicable FDA regulations, guidance, and company policies. Narrative Development & Data Integration Translate complex scientific information into compelling regulatory narratives. Collaborate with scientific and technical experts to identify and integrate the data needed to support regulatory submissions. Regulatory Strategy & Cross-Functional Leadership Support regulatory strategies that enable product commercialization. Identify and resolve issues that could impact submission readiness. Serve as a regulatory subject matter expert on cross-functional project teams and monitor evolving regulatory requirements. Qualifications 8+ years of regulatory affairs experience in tobacco, pharmaceuticals, or other FDA-regulated industries. 5+ years of regulatory/scientific writing experience or evaluation of FDA applications for tobacco products. Demonstrated leadership in complex regulatory writing projects and cross-functional content integration. Strong knowledge of FDA tobacco product regulations and submission requirements. Expertise in FDA premarket applications, post-market reporting, and CTP processes. Exceptional writing, editing, and communication skills. Advanced scientific degree (PhD, ScD, PharmD, MS, MPH, or equivalent) preferred. Compensation & Benefits Base Salary: $176,000 - $220,000 PMI Offers a Competitive Compensation Package Including Annual bonus eligibility Medical, dental, and vision coverage 401(k) with company match Generous PTO Wellness, commuter, and pet insurance benefits Smart Work hybrid flexibility Why PMI? Shape the future of a smoke‑free world. Work alongside talented global colleagues. Grow within a large, international organization. Join an inclusive culture where everyone's contributions are valued. PMI is an Equal Opportunity Employer. To learn more, visit . 33649 #J-18808-Ljbffr