Regulatory Affairs Associate – Local Regulatory Affairs Operations

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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

• Focus on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. • Partner with cross-functional teams to ensure timely submissions and maintain regulatory dossiers.

🎯 Requirements

• 2+ yrs experience in support regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers. • Working knowledge on EU procedures including centralized procedures coordination and management. • Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, Article 31 & other post approval variations & MAA’s. • Assist with DHCP (Direct Healthcare Professional Communication) related activities and commitments follow-up • Manage submissions through local Health Authority portals as required • Handle post-approval lifecycle management activities and regulatory communication-RIMS (Regulatory Information Management Systems)-VEEVA Vault • Support linguistic review processes including translation review and coordination • Conduct readability testing and support artwork (AW) review, mock-ups, and approvals • Support promotional material review including Abbreviated Product Information (API) creation or updates and Regulatory Affairs review processes (including UK pre-vetting) • Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level.

🏖️ Benefits

• Health insurance • Professional development opportunities