What You Will Do
- JOB SUMMARY
FDA Combustible Product Regulatory Lead is responsible for leading regulatory strategy, preparation, coordination, submission of FDA regulatory filings for combustible tobacco products, including Substantial Equivalence (SE) Reports, SE Exemption Requests, amendments, other Center for Tobacco Products (CTP) submissions. R ole serves as primary regulatory lead for submission-related activities, ensuring high-quality, scientifically sound, compliant submissions. Position partners with Marketing, Product Development, Manufacturing, Quality, Supply Chain, external stakeholders to support product authorizations, maintain regulatory compliance throughout product lifecycle. Key responsibility is managing Combustible Related Regulatory Activities, including deficiency letters, information requests, technical reviews, while driving cross-functional efforts needed to achieve successful regulatory outcomes.
- WHAT YOU WILL DO
FDA Submission Leadership - Lead planning, development, compilation, review, submission of FDA regulatory filings for combustible tobacco products. Develop, execute regulatory submission strategies supporting new product introductions, product modifications, lifecycle management activities. Manage submission, deliverables, critical milestones to ensure on-time regulatory submissions. Ensure regulatory dossiers are scientifically robust, accurate, aligned with FDA requirements, guidance. Serve as primary submission lead across cross-functional teams.
Substantial Equivalence (SE) & Regulatory Programs - Lead preparation, submission of SE Reports; exemption requests, related FDA regulatory applications. Evaluate product modifications, manufacturing changes to determine appropriate regulatory pathways. Coordinate comparative assessments between new, predicate products. Ensure consistency between product specifications, manufacturing information, scientific data, regulatory documentation. Support development of regulatory strategies to facilitate successful FDA review, authorization.
FDA Deficiency Response Management - Analyze FDA deficiency letters, information requests, review comments, other regulatory correspondence. Develop comprehensive response strategies, remediation plans. Coordinate subject matter experts to generate supporting scientific, manufacturing, quality documentation. Author, review technically sound responses that address FDA concerns effectively, within established timelines. Maintain tracking, management of commitments resulting from FDA interactions.
Cross-Functional Collaboration - Partner closely with Manufacturing, Quality Assurance, Product Development, Product Stewardship, Marketing, Legal, Supply Chain teams. Coordinate collection, review of product, manufacturing, ingredient, packaging, and specification information required for submissions. Provide regulatory guidance regarding product changes, process modifications, and business initiatives. Support leadership decision-making through regulatory risk assessments and strategic recommendations.
Regulatory Intelligence & Compliance - Monitor evolving FDA regulations, guidance documents, enforcement trends, and industry developments impacting combustible tobacco products. Conduct routine reviews of published FDA Substantial Equivalence Orders, Exemption Requests, authorization decisions, and associated review documentation to identify regulatory precedents, derive strategic learnings, and strengthen future submission strategies. Interpret regulatory requirements and communicate implications to stakeholders. Support post-submission activities, amendments, annual reporting requirements, and lifecycle management initiatives. Participate in regulatory inspections, audits, and internal compliance programs as required. Identify regulatory risks and recommend mitigation strategies.
Qualifications
- REQUIRED MINIMUM QUALIFICATIONS:
• Bachelor's degree in Chemistry, Toxicology, Biological Sciences, Engineering, Public Health, Regulatory Affairs, or a related scientific discipline.
• Advanced degree (MS, MPH, MBA, PhD, or equivalent) preferred.
• Minimum 7 years of experience in Regulatory Affairs, Regulatory Science, Product Stewardship, Manufacturing Compliance, or related functions.
• Minimum 3-5 years of direct experience supporting FDA tobacco product submissions.
• Demonstrated experience leading Substantial Equivalence (SE) submissions and managing FDA review processes.
• Experience authoring or coordinating responses to FDA deficiency letters and information requests.
• Proven ability to lead complex cross-functional regulatory projects.
Work Environment and Physical Demand
What We Offer
• Competitive benefits package that includes medical/dental/vision/life insurance/disability plans
• Dollar for dollar 401k match up to 6% and 5% annual company contribution
• 15 Company-paid holidays
• Generous paid time off
• Employee recognition and discount programs
• Education assistance
• Employee referral bonus program
• Hybrid workplace - remote / in office
• Summer hours
• Casual dress policy Monday through Friday
Annual Base Salary Range: $138417.00 - $184555.00
Final compensation will be determined based on experience, qualifications, and internal equity. This role may also be eligible for annual bonus or incentive compensation.
Applicant Information
This job description describes the essential functions of the job at the time the job description was created, but it is not an exhaustive list of tasks, duties and responsibilities. In addition, the position may evolve or change over time and such changes may not be reflected in the job description until it is next updated.
