Regulatory Affairs Consultant - CMC Biologics

May 6

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Parexel

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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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Develop submission strategies and plans for post-approval CMC activities such as 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 the quality control and production departments to ensure compliance with regulatory requirements. • Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. • Manage projects within all Regulatory Information Management systems, ensuring the maintenance of 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 in writing CMC (technical) sections of regulatory documents such as registration files or variations. • Knowledge of biological processes. • Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. • Understanding of qualification/validation principles. • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. • Team spirit, flexibility, accountability, and organizational skills. • Fluent in English (written and spoken).