Senior Regulatory Affairs Associate – Safety Labelling

🔥 18 hours ago

🌐 Romania, Croatia, +3 more countries – Remote

🇷🇴 Romania – Remote 🇭🇷 Croatia – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• Plan, coordinate, and deliver global and regional safety labelling activities and regulatory submissions throughout the product lifecycle • Execute safety labelling regulatory activities while maintaining compliance with client procedures, regulatory requirements, and internal systems and processes • Assess emerging safety information, regulatory commitments, and pharmacovigilance outputs to determine labelling impact, submission requirements, implementation timelines, and regulatory risks • Author, review, and maintain regulatory documentation, including Module 1 content, and prepare submission-ready dossiers with subject matter experts and stakeholders • Manage end-to-end safety labelling submissions, including planning, dossier compilation, submission package preparation, RIMS maintenance, health authority query responses, and post-approval implementation • Serve as the primary Global Regulatory Affairs contact for assigned safety labelling activities • Maintain and oversee global and regional product information, including EU Product Information • Coordinate linguistic review, translation, readability testing, and implementation activities for safety labelling updates • Support development, maintenance, and implementation of CCDS, CCSI, and associated local labelling documentation • Provide regulatory support for safety-related updates arising from PSURs, signal evaluations, risk management activities, and other pharmacovigilance initiatives • Support change control processes and ensure approved changes are implemented within required regulatory timelines • Coordinate with publishing, operations, and affiliate teams on regulatory dossier assembly, validation, submission, and implementation • Liaise with health authorities, affiliates, and stakeholders on safety labelling matters and regulatory questions • Monitor and communicate changes to global regulatory requirements, guidance, and labelling standards • Develop and maintain submission plans, trackers, metrics, and regulatory records for inspection readiness and compliance monitoring • Contribute to cross-functional regulatory and safety governance teams

🎯 Requirements

• University degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline • Working knowledge of global and regional regulatory requirements for medicinal product safety labelling and lifecycle management, including EU labelling requirements • Understanding of CCDS, CCSI, and their implementation into product information and artwork • Knowledge of safety signal management and the impact of confirmed safety signals on product labelling • Understanding of regulatory submission processes, including Module 1 documentation, lifecycle management activities, and health authority interactions • Familiarity with Regulatory Information Management Systems (RIMS) and electronic document management systems • Strong planning, organizational, and time management skills, with the ability to manage multiple priorities and deadlines • Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and propose practical solutions • Excellent communication, stakeholder management, and interpersonal skills, with the ability to collaborate effectively across cross-functional teams • Fluent in English, both written and spoken

🏖️ Benefits

• Flexibility in working location across various European locations • Home-based or office-based working