Director, New Product Compliance

Swisher International•Jacksonville, FL

About The Position

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.

Requirements

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%

Nice To Haves

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

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