Regulatory Affairs Associate

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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

• Perform Regulatory Impact Assessments (RIA) for Change Controls raised in TrackWise • Assess regulatory implications of manufacturing, quality, labeling, and product information changes • Manage and maintain regulatory change records within Veeva RIMS • Support implementation of regulatory strategies for post-approval changes • Review, update, and author Module 3 sections of CTD dossiers for medicinal products • Ensure CMC documentation remains current and compliant with regulatory expectations • Support dossier lifecycle maintenance activities across multiple markets • Conduct comprehensive Gap Analysis of Module 3 documentation • Identify compliance risks, data gaps, and documentation deficiencies • Develop and recommend remediation plans and regulatory strategies to address identified gaps • Manage post-approval regulatory activities throughout the product lifecycle • Support maintenance of marketing authorizations across EU markets • Collaborate with cross-functional teams to ensure timely execution of regulatory commitments

🎯 Requirements

• 3+ years of experience in post-approval regulatory activities • Experience with medicinal products registered through European procedures, including CP, MRP, DCP, and National Procedures • Knowledge of post-approval regulatory activities for medicinal products • Experience with regulatory submissions, CMC documentation updates, and health authority interactions • Experience with TrackWise • Experience with Veeva RIMS • Experience reviewing, updating, and authoring Module 3 sections of CTD dossiers • Understanding of applicable regulatory requirements and regulatory expectations • Experience conducting comprehensive gap analyses of Module 3 documentation • Ability to identify compliance risks, data gaps, and documentation deficiencies • Ability to develop remediation plans and regulatory strategies • Ability to collaborate with cross-functional teams and execute regulatory commitments in a timely manner