Regulatory Science (RS) Lead- Regulatory Affairs (EMEA)
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 successful candidate will report to the Head of Regulatory Affairs (RA) EMEA.
We are looking for an experienced manager with profound knowledge of electronic cigarettes (medical devices / consumer goods) who can connect science with regulatory and business requirements and develops a comprehensive regional RS strategy accordingly.
- As the Regulatory Science EMEA Lead, he or she will develop tools, standards/processes and approaches to evaluate and support the safety, quality and performance of JUUL’s e-cigarette products pre- and post launch within EMEA regulatory environments. This will include, but is not limited to scientific evidence generation, analysis and interpretation of studies/data, literature research, provision of guidance to enable and facilitate sound and transparent decision making and external reporting.
- He or she will demonstrate his/her scientific and technical expertise and develop strategies in cooperation with Regulatory Affairs, Scientific Affairs and business functions for e-cigarette related scientific research, with relevance for the global/regional regulatory strategy, including regulatory developments, regulatory compliance and business objectives.
- Expert contributions to relevant market research programs, their presentation to authorities, pre- as well as post-research analysis/assessments will form part of the activities.
- In line with RA’s global strategy and in response to EMEA region requirements he or she will lead the design, development and execution of (region-)specific research and testing programs, data and report generation. Global RA programs will be run/supported on an ongoing basis. Effective management of contracts with external service providers/laboratories in the region will be part of the responsibility.
- He or she will build and maintain a network in the scientific community, engage with health authorities and regulatory agencies in EMEA, establish robust relationships and inform them about JUUL’s science-based evidence, positions and observations. Regular attendance in conferences and relevant meetings will be required.
- In collaboration with RA, Scientific Affairs, Legal and topic relevant functions, he or she will generate science-based content to develop and substantiate positions, statements and timely responses to internal and external requests in the region.
- He or she will establish necessary processes such as for science related content clearance and document repository use on a global and regional level.
- He or she will develop in cooperation with global RA a regulatory science training program and material for regional business & functions involved in communication.
- He or she will support the RA EMEA Senior Director in developing strategic, operational and budget plans.
- Excellent networking, communication and presentation skills, profound experience in electronic cigarette relevant science and good knowledge of the European regulatory environment for e-cigarettes / consumer products are prerequisites to:
- Develop rigorous scientific evidence and to provide scientific expertise around JUUL’s products to support RA EMEA regulatory strategies with a view to promote JUUL’s interests in regulatory and scientific developments
- Define required and critical scientific data and evidence to advice on product developments, successful product launches in EMEA markets and lifecycle regulatory compliance
- Identify and establish regional laboratory capacity
- Plan and initiate new and manage running scientific research programs on a regional level e.g. on evidence creation, risk reduction, possible e-cigarette benefits for adult smokers and long-term effects of e-cigarette use
- Provide science related direction to RA EMEA, regional and global functions with respect to the generation of scientific information (format and content) and the timely collection of scientific / technical data (quality, non-clinical, clinical as applicable) for inclusion in regulatory submissions
- Monitor developments and changes in relevant science fields and regulation in EMEA, conduct impact assessments and provide update and guidance to internal stakeholders
- Engage cooperatively and transparently with health authorities and other stakeholders to foster an evidence-based understanding for our products and respond to concerns. Generate proactively, in collaboration with global RA science-based positions and communication material to engage and support engagement
- Establish and maintain a network with health authorities and technical institutions (e.g. surveillance laboratories). Plan, execute and lead meetings and interactions in cooperation with regional functions
- Review and clear scientific evidence e.g. for internal and external communication in EMEA business functions and markets
- Develop and implement processes and systems to standardize information flows, control and access to data repositories in alignment with global RA.
- Develop and support the development of RA relevant presentations, communications / training materials from a scientific perspective
- Support RA EMEA in developing Annual Operating Plans
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- PhD in toxicology, chemistry or relevant science field.
- 10 years experience in Regulatory / Scientific 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, executing and managing scientific programs and strategies for successful e-cigarettes / consumer products’ support and launches
- Confirmed history of managing third party vendors, e.g. scientific laboratories / service providers
- Comprehensive knowledge of European e-cigarette relevant regulation and understanding of scientific data requirements, trends and impact on product
- Good understanding of the working of the EU, its institutions and legislative processes in consumer product regulation and underlying scientific evidence
- 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 understanding of product manufacturing, marketing and sales
- Fluent in spoken and written English; 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.
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