JUUL Labs mission is to impact the lives of the worlds one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the worlds 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 worlds 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:
- Lead and manage teams responsible for:
- Strategy, end-to-end planning, coordination, and execution of major product regulatory filings to US FDA and international regulators; e.g. PMTAs, MRTPAs, EU TPD notifications, etc.
- Global Regulatory Compliance, including developing and maintaining systems and ensuring compliance with various U.S. and international regulations and requirements.
- Provide strategic input on go-to-market decisions and plans.
- Coordinate with functions such as Product Development and Regulatory Science to ensure submission requirements are appropriately accounted for during product and scientific strategy development.
- Lead cross-functional teams on business-critical issues.
- Provide input to and support the development of global regulatory strategy.
- Hire and staff teams; support the development of employees Director level and below.
- As a leader in the Regulatory Affairs organization, coordinate on function-wide initiatives with other members of Regulatory Affairs leadership.
Skills And Requirements
- Bachelors degree and 5-10 years of relevant experience, including preparation of pre-market clearance submissions to regulatory agencies; OR Masters or Law degree and at least 5 years of progressively increasing responsibilities and relevant experience.
- Understanding needed of federal regulations, international regulations, and regulatory guidance as they pertain to the planning, execution, and reporting of preclinical studies and clinical trials and the development and review of electronic submissions.
- Demonstrated ability to persuade, negotiate, and achieve consensus without direct line authority.
- The ability to work effectively with cross-functional colleagues.
- Ability to read, speak, and write fluently in English.
- Excellent planning and organizational skills, as well as sound judgment, problem solving, sense of urgency and follow through.
- Demonstrate strong organizational skills, including the ability to prioritize personal and cross-functional team workload and priorities.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel.
- Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. Well 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
Juul Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. Juul Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Juul Labs in the US.