Senior Manager, Regulatory Affairs

Liquidia Corporation

. Support the development and implementation of global regulatory strategies and contribute to development program planning .

Posted 10/15/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global regulatory strategies, including the preparation and management of regulatory filings and clinical trial execution. Possesses strong collaboration and communication skills to effectively engage with regulatory agencies and internal stakeholders.

Highest-signal resume keywords

Global Regulatory FilingsClinical Trial ExecutionRegulatory AffairsCross-Functional CollaborationRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentINDs/CTAs PreparationNDA/MAA SubmissionsECTD AlignmentDocument Management Systems

Soft Skills

Interpersonal SkillsOrganizational SkillsAnalytical SkillsCommunication Skills

Tools & Technologies

Veeva RIM

Industry Keywords

Bio-PharmaCombination ProductsGxPISO/EU MDRFDAEMA

About the role

Key responsibilities & impact

Support the development and implementation of global regulatory strategies and contribute to development program planning
Assist in identifying regulatory pathways and approval requirements for assigned programs, including regional differences
Prepare, review, coordinate, and supervise global regulatory filings executed by CROs across the US, Europe, APAC, LATAM, and other applicable regions
Support filings including INDs/CTAs and amendments; NDAs/MAAs and supplements/variations; regulatory designation requests; and lifecycle management submissions
Draft and coordinate responses to health authority requests
Support alignment of submissions with global eCTD and combination product requirements
Support clinical trial execution requirements, including registry posting development, essential document packages, informed consent reviews, document redactions, translation oversight, and day-to-day regulatory inputs
Oversee routine regulatory submissions, including DSURs/IND Annual Report appendices, NDA Annual Reports, PADERs, and investigator information
Support relationships with regulatory agencies, including preparation for and participation in health authority meetings and interactions
Maintain working knowledge of regulatory policies, guidance, and environments
Build relationships with relevant stakeholders within the assigned disease area
Summarize and communicate health authority correspondence accurately and promptly to regulatory leadership and project teams
Partner with Clinical Development/Operations, Safety, Project Management, CMC, Commercial, and Medical Affairs
Support regulatory activities for assigned assets, including RA-CMC, Device RA, Reg Ops, and AdPromo
Represent Regulatory in study team meetings and escalate issues to regulatory leadership as appropriate
Support the development and implementation of SOPs for regulatory affairs, clinical research/trials, and related activities

Requirements

What you’ll need

Bachelor's degree in life sciences, engineering, biology, or related field required
Minimum 5 years of industry experience with increasing responsibility in regulatory affairs required
Experience managing regulatory filings and clinical trial execution in the bio-pharma landscape
Experience with a small-to-midsize biotechnology company and/or drug-device combination products preferred
Business travel 10-20% as required
Working knowledge of global regulatory requirements for clinical development and commercialization
Ability to interpret and apply evolving guidance to program execution under the direction of regulatory leadership
Working understanding of drug development and combination product development is a plus
Experience with global regulatory filings, including US FDA and EMA, in support of pre- and post-approval programs
LATAM and Asia experience (i.e., China) a plus
Exposure to global clinical trials and GxP and ISO/EU MDR requirements for combination products
Experience supporting interactions with global regulatory agencies
Experience with document management systems (e.g., Veeva RIM) a plus
Ability to build effective working relationships with internal and external stakeholders
Strong cross-functional collaboration skills with experience supporting alignment in a matrixed environment
Compelling interpersonal, verbal, written, and presentation skills in communication with internal and external stakeholders
Strong organizational skills with the ability to manage multiple deliverables and competing priorities
Sound analytical capabilities in evaluating regulatory risks and supporting mitigation strategies to achieve business goals
High degree of integrity, sound judgment, and commitment to compliance

Benefits

Comp & perks

Competitive compensation package
Medical insurance
Dental insurance
Vision insurance
Short-term disability (STD)
Long-term disability (LTD)
401(k) Savings Retirement Plan
Employee Stock Purchase Plan (ESPP)
Equal opportunity employment
Reasonable accommodation for qualified individuals with disabilities