Regulatory Affairs Lead, Regulatory Affairs (EMEA)

THE COMPANY:

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:

The selected candidate will report to the Senior Director, RA EMEA and lead a small team. We are looking for an experienced manager in the field of Regulatory Affairs for e-cigarettes / consumer goods in Europe.

• Will be responsible for the management of regulatory affairs, statutory regulatory compliance and support of JUUL’s products during their commercial life-cycle in European markets. This includes ongoing monitoring, analysis and risk assessment of relevant regulation / trends to provide strategic guidance to the RA management and the business.
• Will develop, in cooperation with global and other regional functions regulatory strategies to address new and changing regulations and to support the development, registration/notification and successful launch of JUUL’s products and related activities in Europe. He or she will ensure all compliance relevant activities pre-and post-launch have been undertaken.
• Collaborate with the EMEA business functions in market research projects in EU markets and will oversee the coherence of such projects with JUUL guidelines and policies.
• Establish a robust network with internal and external stakeholders in the regulatory / technical field and will participate in relevant meetings to promote JUUL’s interests and competitiveness in RA related matters. Planning, executing of and representing JUUL in meetings with regulatory authorities will form an important part.
• Provide options and solutions to address and solve RA related topics, issues and questions, and drive timely decision-making at the appropriate management level.
• Support RA functions in developing and implementing adequate processes and systems to ensure effective and a high level quality for document management.
• Excellent networking, communication and presentation skills, profound technical / scientific experience and an excellent knowledge of the European regulatory environment for e-cigarettes / consumer products are prerequisites to:
• Develop regulatory strategies for successful product launches in cooperation with relevant global and regional functions
• Monitor developments and changes in relevant legislation / regulation, conduct impact assessments and provide regulatory guidance to internal stakeholders. The relevant regulation includes, but is not limited to e-cigarette category specific and non-specific regulations. Update the RA EMEA management on a regular basis
• Provide regulatory direction to RA EMEA, regional and global functions with respect to the generation of regulatory information (format and content) and the collection of scientific/technical data (quality, non-clinical, clinical as applicable) for inclusion in regulatory submissions
• Advice on, review and approve submissions and relevant information, such as data and documents intended for inclusion in submissions pre- and post launch (e.g. study protocols and reports, statistical data, market research).
• Initiate or support the development of internal and external positions in alignment with RA and JUUL’s global positions ● Direct the management and resolution of regulatory affairs related issues in Europe region / markets
• Establish and maintain a network with external stakeholders, such as regulatory authorities and technical institutions (e.g. standardization bodies) and plan, execute and lead meetings and interactions. Ensure positioning, activities and communication are aligned with RA and JUUL’s strategy and policies
• Coordinate JUUL standardization activities in European markets and cooperate closely with HQ functions to ensure a global strategy coherence
• Develop and contribute to responses to external requests / inquiries from regulatory agencies, consumers and NGOs in cooperation with regional and global functions
• Develop and support the development of RA relevant presentations, communication / training materials
• Support RA EMEA in developing Annual Operating Plans for RA Europe

Education and Experience

• Master degree in Regulatory, Science, Legal or related fields; PhD is a plus
• Minimum 7 years experience in Regulatory Affairs for e-cigarettes / consumer goods in Europe with proven record of interaction with authorities at national and regional level
• Demonstrated strong capacities in developing and executing regulatory strategies for successful e-cigarettes / consumer products’ launches
• Strong business acumen combined with solid regulatory / technical / scientific knowledge - connecting regulatory and product compliance / technical / scientific issues with RA Europe requirements, regional and company objectives
• Extensive experience in European e-cigarette relevant regulation and understanding of trends and impact on product
• Knowledgeable of the working of the EU, its institutions and legislative processes in consumer product regulation
• Comprehensive knowledge of other EU consumer product regulations such as general product safety / chemical / (W)EEE and waste regulations
• Experience in working in industry associations and standardization bodies
• Excellent communication, presentation and argumentation skills, experienced in working with all hierarchy levels in a company. Adapts style and uses persuasion in delivering messages. Presents and defends analysis and secures approval on complex matters
• Strong project management capacities and drive; result oriented; stress tolerant, can work simultaneously on projects in parallel and against flexible timelines
• Good general technical and scientific understanding of consumer product testing, manufacturing, marketing and sales
• Fluent in spoken and written English and another European/EU language; additional regional languages are a plus
• Experience in medicinal product/medical device authorizations is a plus

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

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.