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.
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