Manager, Regulatory Affairs – Operations

🔥 4 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
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• No salary listed.

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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

• Manage, organize, and deliver regulatory submissions and submission-ready documents • Ensure efficient and compliant document workflows between departments • Provide expertise in preparing regulatory submission documents and dossiers • Coordinate and execute document workflows, including formatting and finalizing documents through submission readiness • Use regulatory operations tools to maintain high document quality standards • Collaborate with teams on regulatory requirements and compliant submission documents • Manage submission document workflows and deadlines across the product portfolio • Coordinate activities among relevant functions within submission plans • Monitor industry trends related to global electronic submissions and eCTD document preparation • Participate in maintenance activities for Regulatory Information Management Systems and EDMS, including Veeva Submission and Archive Vaults • Support eCTD publishing activities using systems such as Lorenz docuBridge • 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 Regulatory Operations management with administrative and compliance tasks, including Health Authority portal submissions, RA SOW/PO system administration, and metric reporting for leadership

🎯 Requirements

• 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, quality control, submission-ready preparation, and finalization 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 • 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 in project timelines • Outstanding written and verbal communication skills • 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, speaking, reading, and writing • 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 are available across Telix • Equal opportunity employment

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