Senior Regulatory Affairs Associate – Artwork Coordinator

🔥 17 hours ago

🌐 Serbia, Croatia, +3 more countries – Remote

🇷🇸 Serbia – Remote 🇭🇷 Croatia – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Coordinate the progression of approved labelling content through artwork development, review, approval and implementation • Support the creation and maintenance of package leaflets, cartons, labels, foils, booklets and other packaging components • Ensure approved regulatory content is accurately transferred into artwork and packaging assets • Track artwork activities and monitor delivery against agreed timelines, priorities and client requirements • Coordinate with EU and US labelling leads to implement approved labelling changes • Partner with local regulatory teams and artwork or change-control teams to facilitate market-specific updates • Act as a central point of contact between Regulatory Affairs, Labelling Operations, artwork production, graphics and other stakeholders • Escalate risks, delays, discrepancies and unclear requirements for resolution • Lead change-control activities associated with labelling and packaging updates • Maintain documentation, records and approval evidence throughout the artwork process • Perform activities in accordance with regulatory requirements, internal procedures and quality standards • Lead investigation and resolution of artwork-related issues, content discrepancies and implementation questions • Maintain accurate status information for artwork activities, approvals and implementation milestones • Use document management, artwork management and workflow systems • Coordinate translations and multilingual artwork requirements • Contribute to process improvement and consistency across labelling and artwork operations • Provide guidance and training to junior team members

🎯 Requirements

• University degree in life sciences discipline • Experience in pharmaceuticals, biotechnology, consumer health, healthcare or another regulated industry • Experience or knowledge of artwork management, change control, translations, graphics, regulatory labelling, packaging or technical documentation • Strong organisational skills and attention to detail • Ability to manage multiple activities and priorities • Clear written and verbal communication skills • Ability to work effectively across functions and regions • Ability to follow controlled processes, maintain accurate records and identify inconsistencies • Proficiency in electronic workflow and document-management systems • Fluent in English, written and spoken

🏖️ Benefits

• Home or office based work arrangement • Full-time employment