Senior Regulatory Affairs Consultant

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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

• Partner with study teams to manage required regulatory activities, standards, and deliverables associated with CTA submission development • Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, assess impact, and present global submission delivery status • Support and lead global team efforts to ensure high-quality, compliant submission components • Manage compilation of the core package build and contribute to CTA and documentation authoring • Escalate, inform, and resolve issues affecting submission builds or global submission delivery logistics with regional and local partners or Health Authorities • Ensure client work is performed and delivered on time and meets business and client quality expectations • Act in a client-facing role with guidance and support from line management

🎯 Requirements

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline • Extensive experience in a CRO/Pharma • Experience in clinical trial submissions to competent Regulatory Authorities • Client-focused approach to work • Excellent written and verbal interpersonal and intercultural communication skills • Critical thinking and problem-solving skills • Proficiency in English and the local language, written and spoken • University degree

🏖️ Benefits

• Training and knowledge of Parexel's basic consulting models and methodologies • Understanding of the services Parexel provides • Support from senior staff on more complex tasks • Annual performance-based bonus plan for eligible roles • Annual salary review for eligible roles • Total rewards incentives for eligible roles • Comprehensive benefits package