Manager, Regulatory Submissions

Manager, Regulatory Submissions

Juul Labs's mission is to transition the world's billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products. We have the opportunity to address one of the world's most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.

We are a diverse team that is united by this common purpose and we are hiring the world's best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career is compelling, read on for more details.

Role And Responsibilities

The Manager, Regulatory Submissions for the Regulatory Submissions and Compliance team will support major product regulatory filings to the U.S. FDA (e.g., Premarket Tobacco Product Application (PMTA), Modified Risk Tobacco Product Application (MRTPA)).

The position will report directly to the Senior Director, Regulatory Strategy and External Affairs.

The position requires the ability to balance strategic / tactical activities and communicate effectively with a large group of stakeholders including the Regulatory leadership team and executive leaders. Primary responsibilities include :

• 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.

Personal And Professional Qualifications

Education

Juul Labs Perks & Benefits