Manager, Regulatory Affairs (CTRS)

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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)