Regulatory Intelligence Analyst
- San Francisco, CA
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:
JUUL Labs is searching for a Regulatory Intelligence Analyst to join our Regulatory and Scientific Affairs Team. Reporting to the Senior Manager, Regulatory Affairs, you will support the regulatory and scientific affairs program dedicated to JUUL Labs’ signature brand of Electronic Nicotine Delivery Systems (ENDS). In this visible role, you will assist in development, implementation, and maintenance of Regulatory Intelligence systems and processes
- Support in building a regulatory intelligence network that includes global, regional and local regulatory colleagues and provides the opportunity to share ongoing and emerging regulatory topics and issues that are relevant to the ENDS business
- Develop processes/systems for the collection of regulatory intelligence information
- Communicate relevant regulatory intelligence information to interested internal stakeholders according to defined processes and standards
- Monitor and assess domestic and international Regulatory developments (e.g. Federal Register publication/notices, Tobacco Product Directive (TPD), International standards, FDA and EU guidelines, etc.) related to the ENDS products.
Regulatory Information Management Systems (RIMS) and Regulatory Market Intelligence System
- Accountable for administration of RIMS to meet the business needs with a focus on regulated functions
- Maintain, update and archive relevant regulatory documents using RIMS solution
- Management of system access and permissions
- Perform change management activities
- Configuration management
- Resolution of technical Issues
- Creation of reports as needed
- Management of user training
- Maintenance of system documentation
- Collaborate with quality team and provide input on SOP creation and maintenance
- Liaise with computer system vendors, IT partners, Quality, Validation and the business to coordinate system implementation activities
- Evaluate and implement new tools that improve the collection of relevant regulatory intelligence information
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 2-4 years professional work experience in an FDA regulated Industry, preferably Tobacco and ENDS products. Regulatory experience in other industries, such as Pharmaceutical, Medical Device, Combination product, would be considered if applicant demonstrates aptitude and willingness to learn the ENDS product area.
- Strong communication skills, in English, verbally and in writing are required to effectively interact internally at varying levels
- Demonstrated relationship building and collaboration skills
- Critical thinking and problem-solving skills
- Business savvy and commercial orientation
- Broad understanding of the ENDS products, regulation and business
- Self-directed and comfortable working within areas of ambiguity
- Previous Regulatory Intelligence experience is a plus
EDUCATION: Bachelor’s degree in a science related discipline including, but not limited to, biology, chemistry, aerosol science, pharmacology and engineering.
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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