Global Regulatory Affairs Operations Submission Manager

April 9

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Telxius

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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

201 - 500 employees

📡 Telecommunications

🚗 Transport

🔐 Security

💰 Venture Round on 2017-09

📋 Description

• Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company. • Supporting the international roll-out of our prostate cancer imaging agent. • Management, organization, and delivery of regulatory submission documents. • Providing expertise regarding preparation of regulatory submission documents and dossiers. • Coordinating and executing document workflows including formatting and finalization. • Utilizing regulatory operations tools to meet quality document standards. • Facilitating workstreams and document preparation tasks within tight deadlines. • Strong understanding of industry standards with strategic thinking for document readiness.

🎯 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 • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development