Regulatory Operations Specialist
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:
JUUL Labs is searching for a Regulatory Operations Specialist to join our Quality and Regulatory Affairs Team. Reporting to the Senior Director, Regulatory Affairs, you will be responsible for the regulatory operations that support JUUL Labs’ signature brand of Electronic Nicotine Delivery Systems (ENDS), also commonly known as e-cigarettes. In this broad scoped role, you will assist the regulatory department in ensuring efficient and compliant regulatory processes. Essential responsibilities include support to quality system initiatives, registration/listing activities, FDA and other agency reporting, regulatory submission preparation, and other operational and/or commercial needs.
- Collaborate with Regulatory Affairs and worldwide affiliates to define process improvements and SOP development relating to the regulatory function.
- Assist with the regulatory submission preparation, coordination of submission content deliverables and final publication in a variety of formats.
- Support tobacco product registrations and listings, using the FDA Tobacco Registration and Listing Module (TRLM) system and e-submission uploads to FDA via the Center for Tobacco Product (CTP) portal.
- Coordinate production SKU forecasts with contract manufacturers. Serve as registration and listing agent on their behalf when applicable.
- Implement best-industry practices in archival repository to effectively manage regulatory documentation (certificates, marketing authorization letters, registrations, declaration of conformity, submissions archival and regulatory correspondence, etc.), which may include VEEVA Vault or equivalent systems for regulatory information management.
- Globally assess emerging regulatory policy development, with emphasis on key commercial markets. Inform cross functional stakeholders and business partners of the impact to timely market introductions.
- Provide regulatory input to product lifecycle planning. Actively participate in change control management.
- Provide audit support (internal, external, corporate), representing the regulatory function.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 3-5 years of experience in a regulated industry – Tobacco (including e-cigarettes), Medical Device, Pharmaceutical, Biotechnology, Cosmetics.
- Mastery of operational concepts and technical/scientific principles.
- The ability to understand and interpret legislation, regulations and complex guidance that must be translated into actionable plans and/or approaches.
- Planning/organization skills and project lead experience. Have the ability to perform responsibilities independently with minimal supervision.
- Ability to cultivate and influence an extensive support network to successfully complete projects.
- Proficiency in document formatting and Microsoft Office Suite applications.
- Certification in Regulatory Affairs (RAC) or Quality functional area a plus.
- Bachelor's degree (or equivalent) in the sciences (biology, chemistry, physical science etc.), math, engineering, medical fields, information sciences are preferred.
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
- Location. Work in the heart of San Francisco, one of the world’s greatest cities
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