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Liquidia Corporation · 1 day ago

Associate Director, Regulatory Operations and Projects

Morrisville, NC

Full-time

Onsite

Lead/Staff, Director/Executive

8+ years exp

Liquidia Corporation is dedicated to the development of innovative therapies for patients, particularly in the area of pulmonary hypertension. The Associate Director, Regulatory Operations & Projects is responsible for overseeing regulatory operations and infrastructure projects, ensuring compliance and quality of regulatory submissions, and leading initiatives to improve submission management processes.

BiopharmaBiotechnologyHealth CareNanotechnologyTherapeutics

Hiring Manager

Brian Duggan

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

Qualification

Regulatory operationsECTD submissionsRegulatory systems managementDocument managementGlobal regulatory standardsProject managementCommunication skillsAttention to detailLeadershipAdaptability

Required

Bachelor's degree in life sciences, regulatory affairs, or related field

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

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

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

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

Preferred

advanced degree preferred

Prior experience managing regulatory systems (RIM, EDMS) and third-party publishers strongly preferred

Experience working in fast-paced, growth-stage biotech environments desirable

Benefits

Medical

Dental

Vision

STD

LTD

401(k) Savings Retirement Plan

ESPP

Unlimited Paid Time Off

Company

Liquidia Corporation

Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology.

Founded in 2004

Morrisville, North Carolina, USA

51-200 employees