FDA Combustible Product Regulatory Lead

ITG Brands is the third-largest tobacco company in the USA with offerings of some of the most well-known cigarette, cigar, and e-vapor brands. As a member of the globally recognized Imperial Brands PLC family, we are a forward-thinking partner with operational integrity.

ITG Brands is committed to putting consumers at the center of what we do, while creating an innovative workplace where inclusion, creativity, and bold thinking drive progress. This empowers us to bring our true selves to work, to collaborate more effectively through showing our passion and being confident to bring new ideas to the table.

We are not afraid to seize opportunities and make things happen – both individually and collaboratively. We strive to exceed expectations by seeing things differently and doing things differently. This truly is a place where we all share a challenger mindset which drives our success.

- JOB SUMMARY

- WHAT YOU WILL DO

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…