Regulatory Affairs Consultant – CTA

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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

• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required. • Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities. • Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines. • Manages the compilation for core package build, contributing to CTA and authoring documentation as required. • Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

🎯 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, both written and verbal • Critical thinking and problem-solving skills • Proficiency in English and local language (written and spoken).

🏖️ Benefits

• Comprehensive benefits package to ensure your success and growth in this role. • Training and knowledge of our organization's basic consulting models and methodologies. • Support from our senior staff to accomplish more complex tasks successfully.