Senior Manager, Regulatory Affairs – Operations

🔥 5 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• Lead and oversee regulatory publishing operations across the product portfolio • Ensure submission timelines, quality standards, and regulatory requirements are met • Implement, roll out, support, and continuously optimize the Lorenz docuBridge publishing platform • Develop best practices, training materials, and user support processes • Establish and monitor KPIs and operational metrics for submission readiness, publishing quality, inspection preparedness, and departmental efficiency • Provide leadership and mentorship to regulatory operations staff and cross-functional stakeholders • Serve as a subject matter expert for electronic publishing, submission validation, and Health Authority gateway requirements • Lead cross-functional process improvement initiatives • Support vendor relationships and publishing service providers • Partner with Regulatory Affairs leadership on strategic planning, resource forecasting, and submission prioritization • Champion inspection readiness and compliance • Maintain awareness of industry trends, evolving regulations, and global e-submission best practices • Participate in maintenance activities for RIMS and EDMS, including Veeva Submission and Archive Vaults • Refine procedures, standards, templates, and style guides for submission documents • Facilitate Health Authority portal submissions, administer internal RA SOW/PO systems, and generate leadership metric reports

🎯 Requirements

• Bachelor's degree or equivalent experience is required • 8+ years of experience in Regulatory Affairs Operations • 3-5+ years of leadership, people management, or functional leadership experience • Experience supporting global regulatory submissions, including FDA, EMA, Health Canada, and MHRA • Experience preparing, formatting, QCing, and finalizing 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 • Knowledge and awareness of the Lorenz docuBridge publishing platform, with aptitude to learn and use it effectively • 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 on project timeline impacts • Outstanding written and verbal communication skills • Ability to work independently in a remote setting across multiple time zones and effectively collaborate in a team environment • General understanding of dossier Life Cycle Management is desired • Fluent in English; additional European language is an asset

🏖️ Benefits

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