Senior Regulatory Affairs Associate – Clinical Trial Application

🕒 July 3

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Logo of Parexel

Parexel

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

• Lead end-to-end CTA project management across multiple studies and countries • Plan, track, and deliver submissions aligned with timelines and regulatory requirements • Manage risks, dependencies, and complexities in global regulatory environments • Collaborate with cross-functional global teams • Build and maintain stakeholder relationships and resolve conflicts

🎯 Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, or related field • Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar • Experience in Clinical Trial Application submissions (EU CTR & ROW) • Strong project management experience in a global/matrix environment • Familiarity with clinical trials and regulatory processes

🏖️ Benefits

• Health insurance • Work-life balance initiatives • Professional development opportunities • Collaborate with global teams

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