Regulatory Affairs Consultant

🕒 June 30

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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

• Support global regulatory lifecycle management activities across EU, US, and international markets • Contribute to regulatory strategy development for global and regional submissions • Prepare, coordinate, and deliver regulatory submission packages (Modules 1–5) • Manage post-approval changes, variation submissions, and follow-up activities • Handle Health Authority queries and ensure timely responses • Provide submission management support including planning, coordination, and timeline tracking • Maintain accurate records in Regulatory Information Management (RIM) systems • Support safety-related regulatory activities such as aggregate reports and urgent safety updates • Assist with audit, compliance, and inspection readiness activities

🎯 Requirements

• 8 to 11 years of relevant experience • Strong knowledge of EU & US regulatory procedures and post-approval requirements • Experience in global submission management and lifecycle maintenance • Understanding of regulatory documentation and compliance standards • Strong coordination and stakeholder management skills. • B.Sc. / M.Sc. / B. Pharmacy / M. Pharmacy

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development