Regulatory Affairs Consultant – CTA

🔥 0 minutes ago

🇭🇺 Hungary – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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, with responsibility for required regulatory activities, standards, and deliverables associated with CTA submission development • Complete associated documentation as required • 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 components and submissions • Manage compilation for core package build, contributing to CTA and authoring documentation • Escalate, inform, and resolve issues affecting submission builds or global submission delivery logistics with regional and local partners or Health Authorities • Work under the general direction of a Project Lead and/or Technical SME • Deliver client work on time and according to business and client quality expectations • Potentially 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, both 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 offers • Support from senior staff to accomplish more complex tasks