Senior Regulatory Affairs Associate – CTA, MAA

🔥 2 minutes ago

🇨🇿 Czechia – Remote

⏰ Full Time

🟠 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

• Prepare, submit and maintain Clinical Trial Applications (CTAs) acting as Local Regulatory Contact (LRC) and/or Regulatory Lead (RL) • Support CTIS submissions, amendments, notifications and regulatory interactions with regulatory authorities • Manage post-authorisation activities, including variations, renewals, transfers and other lifecycle maintenance procedures • Review and update product information documents (SmPC, PIL, labelling texts) and artwork materials in compliance with local and EU requirements • Coordinate with internal project teams, clients and regulatory authorities to ensure timely and compliant submissions • Track regulatory commitments, maintain documentation and support regulatory strategy implementation • Work under the general direction of a Project Lead and/or Technical SME, ensuring client work is delivered on time and meets quality expectations • Potentially act in a client-facing role with guidance and support from line management

🎯 Requirements

• University degree in a life science discipline • Previous regulatory affairs experience in CTA and MAA activities within the EU • Good understanding of Czech/EU clinical trial and medicinal product legislation • Experience with lifecycle management activities (variations, transfers, renewals) and product information maintenance • Strong organizational skills, attention to detail and ability to manage multiple projects simultaneously • Effective communication skills and ability to work independently in an international environment • Fluent in English, written and spoken