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:
- 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