Regulatory Science Lead

Who We Are
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.

What You Will Do

• JOB SUMMARY

We are seeking a highly experienced and scientifically driven professional to lead the development and submission of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for Tobacco Products (CTP). The ideal candidate will hold a PhD in a relevant scientific discipline and possess deep expertise in regulatory strategy, toxicology, clinical studies, and FDA engagement.

• WHAT YOU WILL DO
• Lead the strategic planning, preparation, and submission of PMTAs and related FDA scientific dossiers. This includes guiding the planning and execution of all scientific studies and protocols required for a PMTA.
• Oversee and direct a multidisciplinary team of scientists, including toxicologists, chemists, and behavioral scientists. The lead is responsible for coordinating their efforts to ensure the scientific data meets all regulatory requirements.
• Interpret FDA guidance and regulatory requirements to ensure compliance and scientific rigor.
• Manage external consultants, CROs, and vendors supporting PMTA components (e.g., toxicology studies, human factors, actual use studies).
• Cross-functional collaboration: Act as a primary scientific point of contact, providing expert consultation to internal leadership and other departments
• Develop and maintain timelines, submission plans, and risk mitigation strategies.
• Serve as the primary scientific liaison with FDA CTP during pre-submission meetings, deficiency responses, and post-submission communications.
• Ensure scientific integrity and consistency across all submission materials.
• Monitor regulatory trends and provide strategic input on regulatory pathways and product development.
• Communicate complex scientific concepts and findings clearly and concisely, both orally and in written reports and papers. This includes explaining the rationale for scientific approaches and the conclusions of studies to both technical and non-technical audiences.

Qualifications

• REQUIRED MINIMUM QUALIFICATIONS:
• PhD in Toxicology, Pharmacology, Chemistry, Public Health, or related field.
• 7+ years of experience in regulatory affairs or scientific leadership, preferably in tobacco, pharmaceutical, or consumer health industries.
• Proven track record of leading successful PMTA or FDA submissions.
• Strong understanding of FDA CTP regulations, guidance documents, and scientific expectations.
• Excellent project management, communication, and leadership skills.
• Experience managing external partners and cross-functional teams.
• Acute attention to detail and strong analytical skills for reviewing extensive scientific and regulatory documents.
• PREFERRED QUALIFICATIONS:
• Experience with FDA interactions and regulatory negotiations.
• Familiarity with behavioral science, exposure assessment, and risk analysis.
• Knowledge of tobacco harm reduction and nicotine product categories.
• Ability to translate complex scientific data into regulatory strategy.

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

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.