Regulatory Affairs Consultant – CTA

🔥 9 minutes ago

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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 and completion • Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, assess impact, and present the status of global submission delivery activities • Support and lead global team efforts to ensure high-quality components and submissions compliant with industry, agency, and format guidelines, regulatory strategies, policies, and timelines • Manage compilation of the core package build, contributing to CTA and authoring documentation as required • Escalate, inform, and resolve issues that may impact submission builds or the logistics of global submission delivery with regional and local partners or Health Authorities • Ensure client work is performed and delivered on time while meeting 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 • A few years of experience in a CRO/Pharma • Experience in clinical trial submissions to the competent Regulatory Authorities • Client-focused approach to work • Excellent interpersonal and intercultural communication skills, written and verbal • Critical thinking and problem-solving skills • Proficiency in English and local language, written and spoken

🏖️ Benefits

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