Sr Manager Regulatory Submissions
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- Advanced scientific degree (PhD, ScD, PharmD, MS, MPH, or equivalent) preferred.
Responsibilities
- 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.
- 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.
- 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.
Benefits
- Annual bonus eligibility
- Medical, dental, and vision coverage
- 401(k) with company match
- Generous PTO
- Wellness, commuter, and pet insurance benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
