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Global Regulatory Submissions Director

Remote, USA Full-time Posted 2025-05-22

Our client ("Company"), an industry leader in cannabis hardware, is seeking an experienced Regulatory Submissions Director to be responsible for leading and managing multiple and simultaneous regulatory submissions for e-cigarettes and other nicotine products.

Reporting to the Chief Legal Officer with a dotted line to the Head of Product, this role requires an experienced technical project... manager who can drive cross-functional teams, anticipate and solve technical obstacles, and ensure the efficient and effective compilation and dispatch of both domestic and worldwide regulatory submissions. This position offers a challenging and dynamic work environment, requiring a proactive and strategic contributor who can effectively manage global regulatory submissions while fostering strong cross-functional partnerships and driving continuous improvement initiatives.

PMTA or PMA experience required.

Key Responsibilities: • Lead and manage the planning, overseeing, and dispatch of global regulatory submissions for e-cigarettes and nicotine products. • Anticipate technical obstacles and develop effective solutions. • Drive cross-functional teams to compile regulatory submissions, negotiate timelines, and manage global stakeholder expectations. • Serve as the primary point of contact for leadership communications and manage external regulatory consultants. • Provide guidance on worldwide regulatory submission formats, filing strategies, regulatory approval processes, submission lifecycle management, and compilation workflows. • Partner across multiple functions to troubleshoot technical and quality issues, ensuring efficient use of global resources. • Plan, manage, and track delivery of submission components. • Coordinate with the publishing team for submission publishing activities. • Organize submission review and approval processes. • Stakeholder Engagement • Organize, lead, and participate in internal and external stakeholder meetings, including acquisitions, partnerships, and licenses. • Develop and implement solutions to improve efficiencies and effectiveness.

Requirements: • Regulatory affairs or regulatory submissions experience with the U.S. Food and Drug Administration for tobacco products or other regulated pathways. • Familiarity with the tobacco product registration process, regulations, and guidance (e.g., FDA, TPD). • Strong interpersonal skills. • Effective project management skills. • Excellent time management skills. • Proven ability to manage complexities in a fast-paced, global cross-functional organization. • Strong communication and business writing skills. • Technical proficiency with publishing tools, global submission validation tools, document management systems, FDA electronic submission gateways, and MS Office tools. • Familiarity with submission publishing and compilation principles is ideal. • Proven enterprise mindset and quality-driven approach. • Decisive, solution-oriented, pragmatic, and customer-focused. • Readily adapts to changing priorities and remains composed under pressure. • Demonstrated negotiation skills and a positive attitude. • Ability to build productive relationships and influence stakeholders across the organization. • Results-driven and action-oriented. • Highly motivated, self-starter, and forward thinker. • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. • Bachelor’s degree in mechanical engineering, electrical engineering, life sciences, or a relevant discipline preferred; or equivalent combination of education and experience

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