JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. 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 at one of the fastest growing companies is compelling, read on for more details.
Role and Responsibilities
JUUL Labs is searching for a Regulatory Affairs Specialist to join our Quality and Regulatory Affairs Team. Reporting to the Senior Director, Regulatory Affairs, you will support the regulatory affairs program dedicated to JUUL Labs’ signature brand of Electronic Nicotine Delivery Systems (ENDS). In this visible role, you will assist in defining global regulatory requirements, interact with the product development, country launch, labeling and commercial
teams for domestic and international product registrations.
- Assist the Regulatory team in drafting and reviewing submissions (Premarket Tobacco Product applications (PMTA), Modified Risk Tobacco Product (MRTP), etc.) to obtain market authorization for JUUL’s products
- Review changes and provide global regulatory assessment for timely implementation
- Monitor and assess domestic and international Regulatory developments (e.g. Federal Register publication/notices, Tobacco Product Directive (TPD), International standards, FDA and EU guidelines, etc.) related to the ENDS products.
- Reviews product labeling to ensure conformance with applicable Regulatory requirements and/or approved product claims
- Maintain, update and archive relevant regulatory documents using Regulatory Information Management System (RIMS) solutions as administrator
- Collaborate with quality team and provide input on SOP creation and maintenance
- Liaison with JUUL’s international regulatory personnel to address questions and issues that arise as a part international product launch requirement (country registrations, labeling, Tobacco Product Directive (TPD) compliance, safety testing, and EU Commission uploads etc.)
- Maintain establishment registrations and listings information, as required.
Personal And Professional Qualifications
- Minimum of 3-5 years professional work experience in an FDA regulated Industry, preferably Tobacco and ENDS products. Regulatory experience in other industries, such as Pharmaceutical, Medical Device, Combination product, would be considered if applicant demonstrates aptitude and willingness to learn the ENDS product area.
- The ability to understand and interpret legislation, regulations and complex guidance that must be translated into actionable plans or approaches.
- Versatility in knowledge areas including product development, clinical trial design, behavior science research, and toxicology.
- Experience in writing regulatory submissions like 510(k), PMA, IDE, NDA, Design Dossier, etc.
- Demonstrated experience with submission to the European Union
- Highly proficient communication skills, both written and verbal
- Established technical writing skills
- Bachelor’s degree in a science related discipline including, but not limited to, biology, chemistry, aerosol science, pharmacology and engineering.
JUUL Labs Perks Benefits:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits