Job Description

Juul Labs is seeking a Manager, Regulatory Submissions to support major product regulatory filings to the U.S. FDA, such as PMTA and MRTPA. This role involves partnering with cross-functional teams, providing regulatory guidance, and preparing technical documentation for submissions.

Responsibilities

• Partner with R&D, Engineering, and Operations
• Cultivate relationships with cross-functional teams
• Provide strategic guidance on regulatory submissions
• Adhere to Regulatory Authority regulations
• Contribute to the preparation of regulatory submissions
• Interpret complex data
• Develop and review submission deliverables
• Identify and resolve potential technical or regulatory issues

Requirements

• Understanding of regulatory environment for product development
• Experience with FDA regulation of tobacco products (PMTA/MRTPA)
• Experience in technical review of regulated products
• Expertise in translating engineering principles into regulatory documentation
• Strong planning and organizational skills
• Strong interpersonal and influencing skills
• Excellent communication skills
• Ability to handle multiple projects
• High ethical standards

Benefits

• No benefits