Manager, Regulatory

3 weeks ago

Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

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.

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