Philip Morris International

Sr Manager, US Regulatory Submissions

Philip Morris International • $176K — $220K *
Washington, DC 20011In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

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.

Responsibilities

  • Author and manage FDA submissions, including various application types and amendments.
  • Prepare supporting regulatory documentation with scientific accuracy and consistency.
  • Ensure compliance with FDA regulations and company policies.
  • Translate complex scientific information into compelling regulatory narratives.
  • Collaborate with experts to identify and integrate necessary data for submissions.
  • Support regulatory strategies that enable efficient product commercialization.
  • Serve as a regulatory expert on cross-functional teams and monitor evolving requirements.

Benefits

  • 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
Full Job Description
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

About Philip Morris International

Philip Morris International Careers

Join the global team at Philip Morris International (PMI), a leading international tobacco company dedicated to innovation and transformation in the industry. At PMI, we offer more than just job opportunities; we provide a platform for professional growth and leadership development in an environment that values diversity and inclusion.

Work You’ll Do

At Philip Morris International, you will be part of a dynamic team that is focused on leading the transformation of the tobacco industry towards a smoke-free future. Engage in innovative work that pushes the boundaries of what is possible in consumer goods. With PMI, you can contribute to industry-leading projects and utilize cutting-edge technology to make a meaningful impact.

Explore Our Diverse Opportunities

Whether you're looking for an internship, ready to start your career, or an experienced professional seeking a leadership role, PMI offers a range of positions to match your skills and ambitions. Explore job opportunities in various fields including research and development, marketing, sales, finance, and more. Each position at PMI is a step towards a future-proof career in a company that prioritizes innovation and leadership.

Grow and Develop with Us

PMI is committed to the growth of its employees. We offer comprehensive benefits and diversity training programs designed to enhance your professional skills and personal development. Our leadership programs foster an inclusive culture that encourages networking and innovation, ensuring that every team member can achieve their career goals.

Be Part of Our Culture

At Philip Morris International, we believe that our strength lies in our diversity. Our inclusive culture welcomes professionals from all backgrounds, empowering them to bring their unique perspectives to our team. Collaboration and respect drive our collective success, making PMI a rewarding place to work.

Join Our Team

Ready to advance your career at Philip Morris International? Search open positions that match your skills and interests. We are always hiring creative, curious, and motivated individuals who are ready to drive innovation in our industry. Prepare your resume, sharpen your interview skills, and become part of a company that’s leading change.

Stay Connected

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Philip Morris International Careers

Discover the opportunities waiting for you at PMI. Join us in making history in a company where your career is as important to us as it is to you. Explore, innovate, and grow with Philip Morris International.
Learn more about Philip Morris International
Size
69,600 employees
Market Cap
$157.8 billion
Industry
Food & Beverages
Net Income
$8 billion
Founded
1900
5 Year Trend
+3.3%
Revenue
$28.6 billion
NASDAQ
PM
* Ladders Estimates

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