Associate Director, Regulatory Operations and Projects

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 andoptimizeRegulatory 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 submissioncontentplans, timelines, deliverables, and communication pathways in collaboration withRegulatory Affairs team membersand cross-functional contributors.
• Oversee publishing, formatting, QC, and submissionto 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

Education and Experience

• Bachelor’s degree in life sciences, regulatory affairs, or related field; advanced degree preferred.
• Approximately 8 years of regulatory operations experience within the biotech or pharmaceutical industry, including hands-on responsibility for eCTD submissions.
• Demonstrated experience leading major regulatory submissions (e.g., IND, CTA, BLA, MAA) and overseeing full lifecycle maintenance.
• Prior experience managing regulatory systems (RIM, EDMS) and third-party publishers strongly preferred.
• Experience working in fast-paced, growth-stage biotech environments desirable.

Technical Knowledge

• Expert understanding of global regulatory submission requirements and eCTD structure, including Module 1 regional requirements.
• Deep familiarity with ICH guidelines, FDA/EMA submission standards, and emerging regulatory technology trends.
• Strong working knowledge of regulatory systems (EDMS, RIM, publishing tools), metadata management, and document lifecycle control.

Skills and Competencies

• Exceptional project management skills with the ability to coordinate multiple submissions and deadlines concurrently.
• Strong document management and formatting skills, including understanding of content development workflows.
• Ability to interpret and apply regulatory requirements to operational processes and system configurations.
• Excellent written and verbal communication skills, with the ability to influence and collaborate across functions.
• High degree of accuracy, attention to detail, and commitment to compliance and quality.
• Ability to work independently, exercise sound judgment, and manage vendor relationships effectively.

Leadership and Attributes

• Proven ability to lead cross-functional teams in a matrixed environment.
• Capability to define and implement operational strategies and process improvements.
• Adaptability and resourcefulness in a dynamic, evolving biotech setting.

Benefits

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.

Recruiting Agencies, Please Note :

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.