Associate Director, Regulatory Affairs

December 12, 2024

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Parexel

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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.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Communicate and champion organizational vision and values. • Regularly communicate with staff to assure effective two-way information flow (e.g., business updates, staff interests, issues, and/or concerns). • Provide a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear. • Define self-development activities to keep current within the industry (e.g., maintain membership in a relevant industry and/or scientific/technical association). • Leverage information from previous projects or other client work to efficiently complete assigned project activities and facilitate business decisions. • Produce quality work that meets the expectations of the client. • Review the work of colleagues for content and quality to ensure client and PC expectations are met. • Assess project issues and develop strategies to meet productivity, quality, and project goals and objectives. • Actively manage performance, including typical HR activities for direct reports (e.g., performance management reviews, salary actions, bonuses, scorecards).

🎯 Requirements

• Over 15 years of relevant experience in clinical trial regulatory submissions. • Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure to the European market. • Proficiency in handling the CTIS database and submitting EU CTR and CDSCO is desirable. • Monitor the profitability of multiple projects/programs through active involvement with project leads in preparing project plans and managing project budgets. • Proactively avoid and resolve issues with revenue recognition. • Work within a team environment or individually based on project needs. • Provide guidance to project team members and act as a mentor to staff. • Work within broad project guidelines and lead issue and conflict resolutions. • Prioritize own workload and the workload of the project team to achieve project scope and objectives. • Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action. • Actively manage performance, including typical HR activities for direct reports (e.g., performance management forms, salary actions, bonuses, scorecards).