Manager, Regulatory Submissions

Detailed understanding of the current regulatory environment and concepts as they apply to product development and authorization in the pharmaceutical, medical device, and/or tobacco industries. Deep, practical experience with FDA's regulation of tobacco products, particularly the PMTA and/or MRTPA pathways. Demonstrated experience in the technical review and evaluation of regulated products, preferably tobacco or other FDA-regulated products. Expertise in translating complex engineering principles, product design specifications, and manufacturing processes into clear and compelling regulatory documentation. Excellent planning and organizational skills, including the ability to prioritize personal and team workloads, as well as sound judgment, problem solving, sense of urgency and follow through. Strong interpersonal skills and the ability to deal effectively with a variety of personnel. Strong influencing skills with proven track record of stakeholder engagement. Demonstrates excellent written, verbal, and interpersonal communication skills including effectively communicating to various management and stakeholder groups, as needed. Able to handle multiple projects simultaneously and prioritizes accordingly with effective time management skills. Highest ethical standards, integrity, authenticity, credibility and character. Superior judgement on maintaining confidential information at all times. Proficiency with relevant software: Excel, PowerPoint, Word (and gSuite equivalents), in addition to general knowledge of shared work environments. Master’s degree or PhD in an engineering discipline (e.g., Mechanical, Biomedical, Chemical, Electrical) or related physical science with 2+ years of relevant experience. Will consider a Bachelor's degree in a relevant engineering discipline with 5+ years of exceptional, directly relevant experience.

Support major product regulatory filings to the U.S. FDA (e.g., Premarket Tobacco Product Application (PMTA), Modified Risk Tobacco Product Application (MRTPA)). Partners with internal R&D, Engineering, Operations, and other Subject Matter Experts to provide interpretation and guidance, ensuring adherence to the submissions strategy and alignment with business needs. Cultivates strong relationships with key cross-functional team members and stakeholders to align on timing and content of submission document drafting, review, and approval. Provides strategic guidance on regulatory submissions, leveraging a deep understanding of agency review processes, common deficiencies, and expectations for engineering and technical data. Responsible for understanding and adhering to applicable Regulatory Authority regulations, guidance, and product standards; keeps abreast of the current state of product engineering, testing, and submission procedures. Contributes advanced engineering knowledge and analytical skills to the preparation of regulatory submissions. Interprets and organizes complex engineering, manufacturing, and product performance data (e.g., design specifications, materials, battery safety, aerosol testing, manufacturing quality control). Develops, writes, and reviews submissions deliverables, including technical summaries, engineering reports, submission summary modules, and response documents. Incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents. Partners with the Regulatory leadership team and other functional groups to help identify or provide input on potential technical or regulatory issues that could impact the target submission date and leads discussions to reach consensus around a solution.