FDA Regulatory Lawyer

Employer
JUUL Labs, Inc.
Location
Washington, DC
Posted
Jul 03, 2022
Closes
Jul 07, 2022
Ref
584631040
Industry
Law
Hours
Full Time
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. ROLES AND RESPONSIBILITES: Reporting to the Vice President, Legal-International and Regulatory, the FDA Regulatory Lawyer is responsible for providing legal and support services related to the regulatory environment focusing on the United States, best practices applicable to JUUL products, including advising relevant internal business partners on appropriate procedures and strategy. The appropriate candidate will have knowledge and understanding of FDA's regulation of tobacco and ENDS products. The successful candidate will have high cognitive capability and the ability to work across multi-disciplinary teams to find creative solutions to problems. Responsibilities Develop a deep understanding of Company's business and products and the applicable regulatory requirements and regimes, including the tobacco and related products regulations and regulations concerning e-cigarettes/vaping. Develop and draft internal policies, playbooks, and other internal guidance. Documentation to help comply with corporate/commercial/regulatory requirements, best practices and industry standards applicable to Company products and operations, including supplementing such materials with day-to-day guidance. Identify legal/compliance gaps or risk areas and work with executive and business team members to develop and implement appropriate-scaled programs to address them. Oversee and operate any remediation programs to ensure ongoing accountability. Structure and negotiate business relationships, transactions, and oversee a wide variety of strategic alliances and business development activities. Draft, review, analyze, and negotiate contracts, memoranda and other relevant legal documents. Work collaboratively with a broad range of people and departments to develop and maintain strong working relationships between legal, finance, product, commercial/marketing, people services, operations, regulatory and supply chain. Actively oversee and manage outside counsel to ensure effective and efficient use. Establish rapport to encourage proactive use of in-house legal counsel. Develop and implement standardized templates and processes. Work with internal and external stakeholders to proactively identify market/commercial risks and ensure appropriate risk mitigation strategies and review committees are in place. Juggle and successfully prioritize competing and voluminous work streams simultaneously. Understand and be able to translate into "plain English" the legal ramifications of varied legal issues (including regulatory requirements) and clearly and succinctly articulate the risks. Provide advice within the context of the broader business and enterprise level objectives. Manage the deal process to achieve thoughtful, successful and timely results. Proactively communicate and manage expectations with multiple stakeholders. Prepare and provide presentations to business partners as needed. Perform special assignments or projects as needed. Education: The successful candidate will be entitled to practice law within the United States and will have obtained an undergraduate degree from a college or university of recognized standing. An ideal candidate will have experience working for or advising a highly regulated US company, with a strong preference for experience within the tobacco or pharmaceutical sector. Experience: Successful track record of at least 7 years of diverse healthcare and/or regulatory and business legal experience. Experience in the healthcare industry and working with business partners. Strong preference for experience working with commercial groups on product management. Experience in positively and successfully managing relationships with a high energy, diverse group of stakeholders across organisational lines. A thoughtful, articulate and effective communicator who can distil and articulate the important aspects of any legal issue to a wide audience of participants. Knowledge, Skills, and Abilities: Business acumen, including the ability to see the "big picture" as well as the detail of specific legal and business issues. High degree of organisation and efficiency with demonstrated attention to detail. Superior written and verbal communication skills (including presentations). Ability to meet aggressive time frames. Ability to build credibility quickly and provide strong legal support for complex and challenging business opportunities. Demonstrated ability to simultaneously manage a variety of assignments and oversee areas of responsibility and prioritize activities in a fast-paced, demanding environment. Able to make decisions quickly but also seek guidance when appropriate. Ability to interact with persuasiveness and confidence. Demonstrated relationship-building skills; ability to appreciate people with different backgrounds and points of view and ability to create an inclusive environment. Personal integrity, sound judgment and strong ethics in business and personal conduct. Adaptable, comfortable with uncertainty and ambiguity, committed to personal and professional growth and receptive to feedback. Highly motivated with a "can do" attitude. Ability to self-direct. 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 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.

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