Senior Regulatory Writing Lead — FDA Submissions (Hybrid)

Philip Morris International; Washington (District of Columbia); Hybrid; USD 176,000 - 220,000; Full time

Benefits offered by this job

Annual bonus eligibility

Medical, dental, and vision coverage

401(k) with company match

Generous PTO

Wellness, commuter, and pet insurance

Smart Work hybrid flexibility

Job summary

Philip Morris International in Washington, D.C. is seeking a Senior Regulatory Writing Lead to drive planning, development, and quality of high-priority regulatory documents for U.S. tobacco and nicotine product submissions.

You will ensure clear, compliant communication with the FDA and partner across PMI US and Global teams. This role combines regulatory strategy, cross-functional leadership, and data integration to support submission readiness and product commercialization, with a focus on

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 preferred (PhD, ScD, PharmD, MS, MPH, or equivalent).

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.

Skills

Regulatory writing

Regulatory affairs

Cross-functional leadership

FDA regulations

Submission readiness

Scientific communication

Education

Advanced scientific degree (PhD/ScD/PharmD/MS/MPH) preferred

Job description

Philip Morris International in Washington, D.C. is seeking a Senior Regulatory Writing Lead to drive planning, development, and quality of high-priority regulatory documents for U.S. tobacco and nicotine product submissions.

You will ensure clear, compliant communication with the FDA and partner across PMI US and Global teams. This role combines regulatory strategy, cross-functional leadership, and data integration to support submission readiness and product commercialization, with a focus on