Regulatory Specialist
Location
United States
Posted
27 days ago
Salary
$110K - $138K / year
Bachelor Degree4 yrs expEnglish
Job Description
• Coordinate the end-to-end preparation, review, and timely filing of postmarket reporting submissions.
• Coordinate with cross-functional teams (i.e., Marketing, Brand, Commercial, Regulatory Science, Legal, etc.) to organize all applicable aspects of postmarket reporting submission materials and ensure compliance with U.S. federal regulatory obligations.
• Manage complex regulatory timelines, ensuring all stakeholders meet milestones for recurring federal filings.
• Assess and identify potential regulatory risks related to advertising, promotion, labeling, and operations and work with Regulatory Leadership to mitigate potential risks.
• Maintain up-to-date knowledge of evolving regulatory requirements and sales and distribution restrictions applicable to tobacco product marketing and advertising in the U.S.
• Perform related duties as assigned, within your scope of practice.
Job Requirements
- Experience in US Regulatory Affairs, preferably with tobacco, nicotine-containing products, pharmaceuticals, or other regulated industries. Experience with coordination and execution or review of regulatory compliance reporting and/or related submissions preferred.
- Working knowledge of FDA and FTC regulations and industry best practices and standards for promotional review and compliance. Experience in regulatory marketing compliance preferred.
- Familiarity with global marketing requirements for tobacco, nicotine-containing products.
- Demonstrated ability to work independently and with cross-functional teams.
- Strong written and verbal communication skills.
- High level of attention to detail, well-organized, and strong analytical and critical thinking skills.
- Ability to thrive in a fast-paced, matrixed environment and adapt to evolving business and regulatory landscapes.
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
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision, disability, and life insurance, plus family support, wellness, legal, and employee assistance program benefits
- 401(k) plan with company matching
- Plus biannual discretionary performance bonuses
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