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
ROLE AND RESPONSIBILITIES: Regulatory Affairs Submission Publisher
- Serve as administrator for internal regulatory information systems (i.e. Veeva Vault platform) including, but not limited to, user management, training, issue escalation and resolution and working with IT and third-party provider.
- Collaborate with submission content contributors (i.e. R&D, Clinical, Preclinical, Manufacturing, Quality) in the planning, preparation and publishing of electronic common technical document (eCTD) submission projects (i.e. PMTA, MRTP, Master Files) and other submissions related to product lifecycle management.
- Perform submission publishing activities, troubleshoot document and/or workflow issues and apply quality control processes to ensure submission integrity.
- Maintain up-to-date knowledge of global standards, guidelines and procedures for regulatory submission publishing. Recommend courses of action when there are updates in requirements.
- Maintain knowledge of guidelines and/or standards pertaining to pre-approval and post-approval regulatory submissions (i.e. eCTD, NeeS, paper etc).
- Develop templates or use existing predefined templates to facilitate the authoring of regulatory submissions. Prepare submission planner as per submission type for US and international markets.
- Maintain and organize regulatory submissions, guidance documents and agency correspondence for company sponsored projects.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- Familiarity with requirements and hands-on experience in implementing RIMS systems.
- Experience in a regulated industry with a Minimum of 4 years of hands-on experience compiling electronic common technical document (eCTD) submissions in both the US and international markets
- Experience with industry standard publishing tools
- Excellent writing and editing skills are essential for the position
- Can effectively manage changing and sometimes competing priorities in a fast-paced environment
- Detail-oriented with a capacity to deliver accurate results on time
- Self-motivated and solution driven
- Ready to embrace a culture of innovation
Bachelor's degree, preferably in a scientific/technical discipline, or equivalent work experience
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
Vapor, JUUL, Work Culture, Fast Paced, Start-up, Growth, Vape, Technology, Software, Hardware, Consumer Electronics, Manufacturing, Design, Product, Disruptive, Revolutionary, Cutting Edge, App, Android, eCommerce, B2C, San Francisco, Bay Area, IoT, San Jose, Los Angeles