Telxius
Telxius is a leading global connectivity provider, specializing in a Tier-1 IP network and an extensive global digital infrastructure. The company operates over 100,000 kilometers of high-capacity submarine cables and terrestrial backhauls, connecting 17 countries with around 100 points of presence worldwide. Telxius offers services such as IP Internet transit, Ethernet, private line, colocation, and security solutions, including DDoS protection. The company is committed to environmental sustainability, promoting the circular economy by refurbishing equipment. With a focus on seamless, secure, and resilient connectivity, Telxius continues to expand its network to facilitate connectivity to the world's main digital hubs.
Towers and Cable
Global Regulatory Affairs Operations Submission Manager
April 9
Telxius
Telxius is a leading global connectivity provider, specializing in a Tier-1 IP network and an extensive global digital infrastructure. The company operates over 100,000 kilometers of high-capacity submarine cables and terrestrial backhauls, connecting 17 countries with around 100 points of presence worldwide. Telxius offers services such as IP Internet transit, Ethernet, private line, colocation, and security solutions, including DDoS protection. The company is committed to environmental sustainability, promoting the circular economy by refurbishing equipment. With a focus on seamless, secure, and resilient connectivity, Telxius continues to expand its network to facilitate connectivity to the world's main digital hubs.
Towers and Cable
📋 Description
• Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. • At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. • The Global Regulatory Affairs (GRA) Operations - Submission Manager is responsible for the management, organization, and delivery of regulatory submission and submission ready documents at Telix, ensuring efficient and compliant document workflows between its departments. • The Submission Manager position is responsible for providing expertise regarding the preparation of regulatory submission documents and dossiers, as well as coordinating and execute document workflows including document formatting and the finalization of documents through to submission readiness with excellent attention to detail. • The position will utilize regulatory operations tools to ensure the highest quality document standards are met across departments, the company, and within agency specifications and expectations.
🎯 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. • Demonstrated experience in preparing documents for submission: Formatting, QCing, submission-ready preparation and finalization of regulatory document for eCTD submission (e.g., New Drug Applications (NDA) and/or EU Marketing Authorization Applications). • Strong organizational skills with an 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 (e.g., Authoring Templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g. CSC Toolbox and Veeva Collaborative Authoring or equivalent). • Strong project management skills; a keen attention to detail; and to assess and advise teams on potential impact or changes in project timelines. • Outstanding written and verbal communication skills, including the ability to communicate effectively with internal colleagues at various levels, and with external vendor partners. • Self-motivated and results-oriented with an enthusiastic attitude and the ability to work independently in a remote setting in multiple time zones where needed as well as build relationships and work effectively in a team environment. • General understanding of dossier Life Cycle Management is desired. • Aptitude for enjoying working with colleagues from different functions and locations and cultures; reaching out proactively, seeking the answer, engaging the team where needed. • Fluent in English (speaking, reading, and writing), any additional European language is an asset.
🏖️ Benefits
• competitive salaries • annual performance-based bonuses • an equity-based incentive program • generous vacation • paid wellness days • support for learning and development
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