Senior Regulatory Affairs Associate – EU Regulatory Intelligence

🕒 March 20

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Continuously track and evaluate new and updated regulations, guidelines, standards, and procedural changes issued by health authorities across assigned regions. • Conduct impact assessments to determine how regulatory changes may affect the organization’s products, filings, labeling, clinical requirements, and lifecycle strategies. • Translate complex regulatory updates into clear, concise summaries and recommendations for Global Regulatory Affairs and local country teams. • Provide regulatory insights to support strategy development, risk assessment, and decision‑making for new registrations, variations, renewals, and compliance activities. • Deliver regular regulatory intelligence briefings, newsletters, and alerts to keep teams informed of relevant changes. • Actively participate in industry associations, regulatory intelligence networks, specialist working groups, and national or regional regulatory forums. • Attend conferences, workshops, and meetings with regulatory authorities to stay informed about evolving expectations and to gather real‑world interpretations of new requirements. • Share knowledge gained from external engagements to enhance organizational awareness and maintain best‑practice standards. • Partner with Global and Local Regulatory Affairs, Quality, Pharmacovigilance, Medical Affairs, and other functions to embed regulatory intelligence insights into operational planning. • Support the development of regional regulatory strategies, considering anticipated regulatory trends and innovation pathways. • Contribute to regulatory risk mitigation plans, scenario forecasting, and strategic recommendations for market access or lifecycle management.

🎯 Requirements

• University Degree in a Scientific or Technical Discipline • Strong understanding of EU regulatory frameworks, laws, and procedures. • Ability to interpret guidelines and policy documents and translate them into operational and strategic impact. • Experience with regulatory intelligence tools, databases, and scientific/regulatory information sources. • Excellent ability to analyze regulatory trends, assess impacts, and identify risks or opportunities. • Strong skills in critical thinking, problem‑solving, and anticipating regulatory expectations. • Ability to synthesize large volumes of information into clear insights for diverse audiences. • Exceptional written and verbal communication skills, capable of explaining regulatory concepts to non‑experts. • Skilled in preparing high‑quality presentations, summaries, and strategic updates. • Fluent in English, written and spoken.

🏖️ Benefits

• Remote work options • Professional development opportunities