Manager, Regulatory Affairs
Bengaluru, Karnataka, India 求人ID R0000024245 Category Regulatory / ConsultingAbout this Role
- 10+ yrs relevant experience in Clinical Trial Regulatory Submissions.
- Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.
- Expertise in handling the CTIS database and submitting EU CTR is desirable.
- Provides guidance to project team members
- Works within broad project guidelines and facilitates issue and conflict resolutions
- Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives
- Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
- Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
- Produces quality work that meets the expectations and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
- Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives
- Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards)
- Assures PAREXEL policies and procedures are communicated to line personnel in alignment with their staff’s local country
- Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear
- Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)
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