Manager, Regulatory

Key Qualifications and Experience:

• Over 10 years of relevant experience in Clinical Trial Regulatory Submissions.
• Proven track record in managing clinical trial studies and serving as a Regulatory Lead for global trials, with specific exposure to the European market.
• Expertise in handling the CTIS database and submitting under EU CTR is highly desirable.
• Provides expert guidance to project team members.
• Works within broad project guidelines, facilitating issue and conflict resolution.
• Prioritizes personal workload and may prioritize the project teams workload to achieve project scope and objectives.
• Seizes opportunities to enhance project efficiency, results, or team performance and proactively takes action.
• Utilizes information from previous projects or client work to efficiently complete assigned project activities and facilitate business decisions.
• Delivers quality work that meets client expectations and reviews colleagues work for content and quality to ensure client and Parexel standards are met.
• Assesses project issues and develops strategies to achieve productivity, quality, and project goals and objectives.
• Actively manages performance, including typical HR activities for direct reports (e.g., performance reviews, salary actions, bonuses, scorecards).
• Ensures Parexel policies and procedures are communicated to line personnel in accordance with local country regulations.
• Provides a comprehensive range of technical and business consulting services, primarily in areas with clear policy or precedent.
• Defines self-development activities to stay current in the industry (e.g., maintains membership in relevant industry and/or scientific/technical associations).

Our commitment to improving health worldwide unites us, driving our dedication to deliver impactful and meaningful results. Join us at Parexel, where your work makes a difference.