Director, New Product Compliance

For the past 162 years, Swisher has been an industry leader known for its iconic products and commitment to high quality standards. With a rich history, Swisher serves adult consumers through a diverse range of businesses, including Swisher Sweets Cigar Company, Helme Tobacco Co., Hempire, Rogue Holdings, and Drew Estate: The Rebirth of Cigars. We have a passion for people and helping them build rewarding careers. If you’re ready to create excitement and drive what’s next in the industry, we’d love to hear from you.

The New Product Compliance Director leads the planning and execution of regulatory compliance strategy for product development and commercialization. This role establishes and maintains processes, systems, and governance to meet compliance requirements driven by governmental policies, regulations, standards, and guidelines, as well as engages internal and external stakeholders, including federal and international regulators and industry groups, to sustain effective compliance in support of business continuity and growth.

Key Responsibilities

• Direct the Company’s regulatory compliance positions across a broad range of new product regulatory issues and set strategy and tactics to address regulatory challenges
• Lead regulatory compliance execution by ensuring collection and evaluation of facts, data, research, and prevailing practices, and by overseeing development and finalization of documentation for FDA and other federal and state submissions
• Assess the impact of regulatory requirements on the new product pipeline and direct action plans, decision pathways, and implementation of compliant courses of action across cross-functional teams
• Oversee development of compliant communications, responses, and submissions to relevant government authorities, including FDA and other federal and state regulators
• Direct development, quality, and readiness of scientific and other supporting data for regulatory product submissions for new products, ensuring documentation integrity and auditability
• Maintain working knowledge of relevant consumer goods product categories and provide compliance guidance to internal teams related to production, marketing, and sales activities, ensuring alignment to regulatory expectations and internal standards
• Partner with operations and quality leadership to direct manufacturing compliance oversight for new product commercialization, including inspection readiness, issue escalation, and corrective action governance

Qualifications

• Bachelor’s degree in a scientific, technical, or closely related field, or equivalent combination of education and directly relevant experience

• 8+ years of progressively responsible experience in regulatory compliance and product submissions within FDA regulated product categories, including direct accountability for submission strategy, development, and outcomes
• Demonstrated ability to recognize and interpret regulatory changes, translate impact to the business, and define actions that inform and influence regulatory policy positions
• Proven ability to interface effectively with FDA and other regulatory agencies, including meetings, written communications, and response strategy
• Demonstrated track record leading successful FDA submissions for regulated products such as tobacco products, drug, device, or combination applications
• High level knowledge of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, and the strategic and operational aspects of FDA and international regulatory requirements, with the ability to interpret relevance to specific product classes and development activities
• Strong written and oral communication skills, strong judgment, and the interpersonal presence to influence at all organizational levels
• Travel: Up to 20%

Preferred Qualifications

• Master’s degree in regulatory science, chemistry, toxicology, biology, psychology, or a related discipline

• Experience working in or advising regarding regulatory science, including the ability to understand, analyze, and manage scientific issues and programs that support submissions

What We Offer

• Base salary and bonus program
• Medical, dental, vision, life insurance effective on date of hire
• Generous 401(k) Plan
• Defined Contribution Plan
• Paid vacation and paid holidays
• Tuition reimbursement

Official Contact Information

• Email: All official emails will come from an @Swisher.com address
• Website: Verify job listings and contact details on https://careers.swisher.com

Important: We will never contact you via Teams, Zoom, or Google Meets. If you qualify for an interview the proper meeting method will be shared with you beforehand. Confidential information should only be shared through secure methods outside of email.