Associate Director, Regulatory Affairs – Operations

Telix Pharmaceuticals Limited

Associate Director for Regulatory Affairs at Telix Pharmaceuticals leading regulatory operational activities. Ensuring efficient and compliant delivery of global regulatory submissions in a dynamic biotech environment.

Posted 6/25/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead the planning, coordination, and execution of global regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs, and amendments), ensuring compliance with global regulatory requirements and timelines.
Provide operational oversight of eCTD submission activities, partnering with external publishing vendors and internal stakeholders to ensure high-quality, timely deliverables.
In partnership with the Senior Director of Regulatory Operations, play a key role in establishing internal publishing capabilities, including defining and leading implementation of publishing capability strategy
Ensure accurate maintenance of regulatory documentation, submission records, and data within regulatory information management and document management systems.
Oversee regulatory document management, tracking, and archival processes to ensure completeness, accuracy, and inspection readiness.
Serve as system administrator for regulatory systems (e.g., Veeva RIM) and act as the internal subject matter expert (SME), driving training, user adoption, and ongoing support in alignment with the defined system strategy and roadmap.
Ensure adherence to global submission standards, including eCTD structure, formatting, and publishing requirements.
Drive the development and continuous improvement of regulatory operations processes, tools, and best practices to enhance efficiency, quality, and consistency.
Lead, mentor, and develop a small team of regulatory operations staff, fostering a high-performing and collaborative team environment.
Oversee vendor relationships and outsourced publishing activities, ensuring performance, quality, and cost-effectiveness.
Partner with Regulatory Affairs leads to operationalize global submission strategies.
Collaborate cross-functionally with clinical, quality, and CMC teams to ensure alignment and execution of submission plans.
Monitor submission milestones and deliverables, proactively identifying risks and driving mitigation strategies to prevent delays.
Ensure ongoing compliance with global regulatory standards and organizational policies.
Maintain inspection readiness and support internal and external audits.
Ensure integrity, accuracy, and completeness of regulatory records and documentation.
Manage submission timelines, milestones, and deliverables across programs.
Lead risk assessment, escalation, and resolution to ensure successful execution of regulatory activities.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences or a related discipline is required.
Minimum of 9 years of relevant experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology industry, including demonstrated leadership experience of at least 2 years.
Experience with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools; experience with Veeva Vault Regulatory is required.
Strong working knowledge of the drug development process and global regulatory frameworks.
Experience managing with and/or overseeing external publishing service providers for regulatory submissions is desirable.
Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as Microsoft Teams.
Experience using project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) to support regulatory timelines and deliverables.
Strong Knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats.
Expertise in eCTD publishing and lifecycle management
Deep knowledge of global regulatory submission requirements.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionseCTD submissionregulatory documentationregulatory information managementdocument management systemsrisk assessmentdrug development processglobal regulatory frameworkseCTD publishinglifecycle management

Soft Skills

leadershipmentoringcollaborationcommunicationteam developmentoperational oversightproblem-solvingstrategic planningvendor managementcross-functional collaboration