Global Regulatory Submissions Director
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.
Bachelors degree in mechanical engineering, electrical engineering, life sciences, or a relevant discipline preferred; or equivalent combination of education and experience
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