Senior Regulatory Affairs Associate – CMC Biologics, Vaccines

🕒 July 15

🌐 Poland, Croatia, +5 more countries – Remote

🇵🇱 Poland – Remote 🇭🇷 Croatia – Remote 🇭🇺 Hungary – Remote 🇱🇹 Lithuania – Remote 🇷🇸 Serbia – Remote 🇮🇹 Italy – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 55%

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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

• Develop submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports • Assess change controls and provide regulatory assessments of quality changes in production and quality control • Review study reports from quality control and production departments for compliance with regulatory requirements • Coordinate submission preparation with manufacturing, supply chain, quality control, quality assurance, regulatory departments, and local companies • Write and/or review submission content related to variations and health authority questions • Manage projects within Regulatory Information Management systems and maintain worldwide submissions • Identify, escalate, and mitigate risks associated with regulatory procedures and activities

🎯 Requirements

• University-level education, preferably in Life Sciences, or equivalent by experience • Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry • Strong understanding of CMC and post-approval regulatory requirements • Experience writing CMC (technical) sections of regulatory documents such as registration files or variations • Knowledge of biological or vaccine processes • Background in validation, Quality Assurance, or production in the pharmaceutical industry • Experience preparing regulatory documentation • Understanding of qualification/validation principles • Proficiency in Word, PowerPoint, and Excel • Experience with Veeva Vault is valued • Fluent in English, written and spoken • Team spirit, flexibility, accountability, and organizational skills

🏖️ Benefits

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