Manager, Regulatory Affairs – Operations

Telix Pharmaceuticals Limited

. Manage, organize, and deliver regulatory submissions and submission-ready documents .

Posted 11/11/2026full-timeRemote • United StatesSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Regulatory Affairs Operations, with a strong focus on managing regulatory submissions and document preparation processes. Proficient in eCTD structure and submission requirements, utilizing tools like Lorenz docuBridge and Veeva for effective document management.

Highest-signal resume keywords

Regulatory Affairs OperationsECTD Submission PreparationLorenz DocuBridge ExpertiseProject Management SkillsAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submissions ManagementDocument FormattingQuality Control (QC)CTD/eCTD Structure KnowledgeDocument Preparation ProcessesDossier Life Cycle ManagementSubmission-Ready Document FinalizationMetric ReportingDocument Workflow CoordinationRegulatory Requirements Guidance

Soft Skills

Strong Organizational SkillsOutstanding Written CommunicationVerbal Communication SkillsAbility to Work IndependentlyTeam Collaboration

Tools & Technologies

Veeva SubmissionVeeva Collaborative AuthoringLorenz DocuBridgeMS WordAdobe AcrobatCSC ToolboxRegulatory Information Management SystemsElectronic Publishing SoftwareEDMSHealth Authority Portal

Industry Keywords

Regulatory LegislationUS/Canada Regulatory ProceduresEuropean Regulatory ProceduresSubmission-Ready DocumentsDocument Management SystemsRegulatory OperationsCross-Functional ActivitiesDocument InfrastructureProcess ImprovementsSubmission Plans

About the role

Key responsibilities & impact

Manage, organize, and deliver regulatory submissions and submission-ready documents
Coordinate compliant document workflows between departments
Guide teams on regulatory requirements and expectations for preparing submission documents
Manage submission plans, preparation deadlines, and cross-functional activities across the product portfolio
Monitor industry trends related to global electronic submissions and eCTD document preparation
Support maintenance activities for Regulatory Information Management Systems and EDMS, including Veeva Submission and Archive Vaults
Use eCTD publishing systems such as Lorenz docuBridge and ensure publish-readiness
Develop and manage document preparation processes using templates and internal style guides
Support and enhance regulatory operations document infrastructure, procedures, standards, templates, and style guides
Provide guidance on document best practices and regulatory requirements; troubleshoot and train as needed
Drive process improvements and uphold quality standards for regulatory submissions
Assist with Health Authority portal submissions, RA SOW/PO system administration, and metric reporting for leadership

Requirements

What you’ll need

Bachelor's degree or equivalent experience is required
7+ years of experience in Regulatory Affairs Operations required
Preferred experience with US/Canada and/or European regulatory legislation and procedures required
Demonstrated experience preparing documents for submission, including formatting, QCing, submission-ready preparation, and finalization of regulatory documents for eCTD submissions such as NDAs and/or EU Marketing Authorization Applications
Strong organizational skills and ability to manage multiple projects and deadlines
Excellent attention to detail and accuracy in documentation
Expert knowledge of CTD/eCTD structure, format, and submission requirements, including Lorenz docuBridge
Experience with MS Word, Adobe Acrobat, electronic publishing software, and document management systems such as CSC Toolbox and Veeva Collaborative Authoring or equivalent
Strong project management skills and ability to assess and advise teams on potential impacts or changes to project timelines
Outstanding written and verbal communication skills for working with internal colleagues and external vendor partners
Ability to work independently in a remote setting across multiple time zones and effectively in a team environment
General understanding of dossier Life Cycle Management is desired
Fluent in English; any additional European language is an asset

Benefits

Comp & perks

Competitive salaries
Annual performance-based bonuses
Equity-based incentive program
Generous vacation
Paid wellness days
Support for learning and development