Senior Regulatory Affairs Associate – Labelling

🔥 2 minutes ago

🌐 Romania, Croatia, +3 more countries – Remote

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

• Draft, edit, format, and maintain CCDSs and associated labelling documents using approved templates and standards • Prepare updates to SmPCs, package leaflets, prescribing information, and carton and container text • Ensure consistency across global and local labelling documentation • Apply regulatory and company guidelines to meet quality and compliance expectations • Maintain version histories and document traceability through change management • Track, review, and reconcile changes across submission versions using document comparison and review tools • Support CCDS updates and labelling changes across multiple markets • Assist with regulatory variations, Health Authority responses, and other lifecycle activities affecting product labelling • Contribute to labelling harmonisation initiatives and document remediation projects • Support preparation of submission-ready labelling documentation within agreed timelines • Ensure documents are accurate, complete, and appropriately formatted before review and submission • Apply Good Documentation Practices (GDP) and internal quality standards • Support continuous improvement of labelling templates, workflows, and authoring processes

🎯 Requirements

• University degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline • Previous experience in Regulatory Affairs, pharmaceutical labelling, technical authoring, or a related discipline • Knowledge of the structure, content, and maintenance of labelling documents • Experience supporting the preparation and maintenance of regulatory documentation • Understanding of Good Documentation Practices (GDP) and quality management principles • Excellent communication, stakeholder management, and interpersonal skills, with the ability to collaborate effectively across cross-functional teams • Fluent in English, both written and spoken

🏖️ Benefits

• Flexibility in working location across various European locations, either office or home based