Associate Director, Regulatory Operations and Projects

Associate Director, Regulatory Operations and Projects

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Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes.

Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary

The Associate Director, Regulatory Operations & Projects is responsible for managing Liquidia’s regulatory operations and regulatory infrastructure projects in the planning, coordination, and execution of global regulatory submissions, document management activities, and evolving regulatory infrastructure to support clinical development and commercialization business objectives. Reporting to the Head of Global Regulatory Affairs, this individual will work with a high degree of independence as the lead on Regulatory operations activities.

The role is responsible for overseeing the management and implementation of the technology related systems and processes in support of regulatory activities. This role ensures the accuracy, quality, and compliance of all regulatory submissions and manages the systems, operational processes, and vendors required to deliver timely, audit-ready regulatory outputs. The Associate Director partners closely with external vendors, Regulatory Affairs, Clinical, Quality, and functional SMEs to drive operational excellence and maintain efficient submission processes for the organization’s commercial development programs.

In addition, the individual will also support activities related to setting standards, best practices, oversight and management of regulatory operations.

Responsibilities

• Administer and optimize Regulatory Operations systems (e.g., RIM, EDMS, eCTD publishing platforms, tracking tools) to drive transparency and efficiency.
• Serve as the operational lead for global regulatory submissions (IND/CTA, IMPD, BLA/MAA, amendments, safety reports, meeting packages, and lifecycle updates).
• Partnering with regulatory SMEs, develop and manage submission content plans, timelines, deliverables, and communication pathways in collaboration with Regulatory Affairs team members and cross-functional contributors.
• Oversee publishing, formatting, QC, and submission to meet global requirements (e.g., FDA/ESG, EMA, Health Canada).
• Maintain submission archives and ensure consistency across all dossiers and lifecycle sequences.
• Provides regulatory operations expertise and leadership to the Regulatory group and cross-functional teams to support business objectives.
• Fosters operational excellence and ensures submission compliance through the implementation of, and adherence to, regulatory operations systems, procedures and associated documents.
• Leads department initiatives focused on the improvement of regulatory submission management processes and tools. This may include developing and contributing to new regulatory processes and providing training support as appropriate.
• Identifies and partners with external stakeholders and vendors to support systems and processes including publishing, submission activities and regulatory intelligence.
• Stays current and monitors any changes in submission regulations and keeps project teams and management informed of such changes as well as maintains familiarity with current and future global regulatory submission standards.
• Oversee third-party publishing vendors and technology providers, including contracting, performance oversight, and issue resolution.
• Support training for functional partners on regulatory systems, authoring standards, and submission processes.

Requirements

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