Senior Regulatory Affairs Manager – CMC, Bio/Vax

🔥 14 minutes ago

🌐 United Kingdom, Croatia, +7 more countries – Remote

🇬🇧 United Kingdom – Remote 🇭🇷 Croatia – Remote 🇭🇺 Hungary – Remote 🇮🇪 Ireland – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇮🇹 Italy – Remote 🇷🇸 Serbia – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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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

• Write CMC sections and scientific rationales for regulatory submissions and responses • Develop and implement variations strategies based on EU guidelines • Coordinate CMC activities across multiple projects • Liaise with global affiliates and manufacturing sites • Provide project leadership and management • Ensure client satisfaction and project quality • Identify new business opportunities and contribute to proposal preparation • Work on a client-dedicated project without people management responsibility

🎯 Requirements

• 10+ years of experience in regulatory affairs • Extensive knowledge of CMC writing and variations strategy • Working knowledge of vaccines or biological processes - required • Experience with regulatory agencies (e.g., FDA, EMA, MHRA) • In-depth understanding of EU guidelines (Variation, ICH, EMA) • Excellent project management and organizational skills • Strong communication abilities and client management experience • Ability to work independently and as part of a team • Fluent in English written and spoken • Additional languages are a plus

🏖️ Benefits

• Home or office based working arrangement • Opportunity to work on diverse projects • Global pharmaceutical environment • Client-dedicated project experience • Additional languages are a plus

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