Manager, Regulatory Affairs

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)