Associate Director, Regulatory Affairs

6 days ago

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Parexel

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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).