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
