Regulatory Manager - EMEA
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, product managers, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
The Regulatory Affairs Manager will provide regulatory support across the JUUL EMEA region, focusing mainly on Eastern Europe. The Manager will also provide support to both the Quality and Compliance functions in this region.
- Leads the Notification of JUUL products in each of the EU Member States prior to launch, in accordance with the Tobacco Products Directive
- Collates scientific information (emissions, ingredients, toxicological reports) required for notification
- Checks the information for completeness and accuracy prior to submission, in collaboration with the US preclinical team and the EMEA Regulatory Affairs team
- Notifies the relevant authorities in the Member States via the notification portals
- Tracks notification status, and updates notifications as and when required
- Provides support to the Scientific and Regulatory Affairs Manager in Eastern Europe
- Proactive in dealing with emerging regulatory issues in this region, including maintaining awareness of pending changes to regulation.
- Supports advocacy and engagement during periods of regulatory consultation.
- Develops network of supportive scientists and physicians in Eastern Europe.
- Supports the promotion and evaluation of Investigator-Sponsored Research (ISR) proposals by scientists and physicians in this region.
- Provides scientific expertise to Medical Science Liaison personnel in Eastern Europe.
- Attends relevant scientific conferences and congresses in the region to maintain awareness of scientific developments and potential impact on regional regulation.
- Supports the EMEA Quality Manager and the EMEA Compliance Manager to identify and resolve emerging quality and compliance issues
- Supports the development of the EMEA Information Library
- Collating and depositing scientific material
- Critiquing scientific publications for use in advocacy
- Maintaining database of supporting and physicians
- Depositing relevant regulatory material eg. regulations
- Interacts with regulators during inspections.
- Maintains scientific awareness of e-cigarettes and JUUL products.
- Interacts frequently with functional peers and senior management.
- Manages interactions with regulators and stakeholders to represent the company products, procedures and processes.
- Develops plans and ensures adherence to budget for projects in responsibility.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- Expert experience in Regulatory Affairs, in either nicotine or other FMCG products
- Familiarity with tobacco/nicotine product regulations and standards or medical device and drug products familiarity a plus
- Robust leadership and communication skills
- Strong analytical and problem solving skills
- Substantial interpersonal/ influencing / negotiation skills
- Solid project management skills
EDUCATION: Bachelor's and Postgraduate degree required in Science or Engineering
JUUL LABS PERKS & BENEFITS
- A place to grow your career. We’ll help you set big goals - and exceed them
- Work with talented, committed and supportive teammates
- Boundless snacks and drinks
- Mobile phone subsidy and discounts on JUUL products
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