FDA Regulatory Counsel (Tobacco and Vapor Products)
JUUL was founded by former smokers, James and Adam, with the goal of improving the lives of the one billion adult smokers. We envision a world where fewer people use cigarettes, and where people who smoke cigarettes have the tools to reduce or eliminate their consumption entirely, should they so desire.
JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC.
JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, software developers, product managers, marketers, sales professionals, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
- Provide legal advice and guidance on compliance with FDA regulations related to advertising and promotion, product claims, labeling, manufacturing, and sale and distribution of tobacco and vapor products.
- Advise business on legal and regulatory requirements relating to external engagement, including for clinical, medical, and scientific affairs and public policy and communications.
- Liaise with government and regulatory bodies, including FDA, on company products, scientific information, formal and informal inquiries, and legislative and regulatory policies.
- Draft comments to regulatory dockets relating to FDA-regulated products, including tobacco and vapor products.
- Draft, negotiate, and provide guidance related to regulatory requirements relating to commercial agreements, including third-party research, contract manufacturers and suppliers, and sales and distribution.
- Advise and consult with all levels of the organization including senior leadership to identify critical legal issues, assess potential legal options, and provide individuals and teams with an analysis and range of possible legal solutions
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 3-6 years of FDA experience as an attorney with a focus on tobacco and/or pharmaceutical, medical device, and/or med-tech products.
- Deep understanding of tobacco regulations relating to advertising and promotion, product claims, manufacturing practices, and sales and distribution is preferred.
- Public-policy and advocacy experience relating to FDA-regulated products.
- Ability to communicate effectively, exercise good judgment in decision making, understand and synthesizes complex issues, and support the execution of business strategy
- Additional qualifications include strong research, writing and analytic skills with the ability to work independently, as well as being part of a team.
- Experienced business lawyer with ability to form strong relationships with business leaders and serve as a counterpart to Quality and Regulatory, Clinical, Medical, and Scientific Affairs, and Marketing functions.
- Ability to execute in a complex matrixed and high-paced environment in collaboration with cross-functional teams.
- Eligible to practice law in California and/or Washington, D.C.
- Juris Doctorate degree with excellent academic credentials and references.
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