Regulatory Affairs Consultant – CMC, US/EU – Biological products

🔥 24 minutes ago

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes • Author and review high-quality CMC documentation (Modules 1–3) for global submissions • Perform CMC dossier gap analyses and provide clear, strategic recommendations • Support and lead global submissions (US, EU, and beyond) from planning through execution • Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders • Act as a key contributor within a dedicated client team, building strong, trusted relationships • Ensure submissions meet global regulatory expectations with precision and excellence

🎯 Requirements

• 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role and 5+ years for a Regulatory Affairs Consultant role • Hands-on experience with commercial biologicals and/or vaccines (required) • Strong knowledge of global regulatory requirements (FDA, EMA, and international markets) • Proven experience in global submission management • Expertise in authoring/reviewing CMC Modules 1–3 to support variations and performing gap analyses • A collaborative mindset with strong communication and stakeholder management skills • Experience with Veeva Vault (RIM/eCTD systems) is a plus

🏖️ Benefits

• Dedicated Client Partnership: Build deeper relationships and drive long-term impact—not just project-based work • Meaningful Work: Contribute to innovative biologics and vaccines that improve patient lives globally • Global Exposure: Gain experience across US, EU, and international regulatory landscapes • Growth & Influence: Be seen as a strategic partner and grow your expertise in a high-visibility role