PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Manager, Regulatory Affairs
About 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)
Additional Information
Experience : 10+ yrs relevant experience
Job ID : R0000024245
Category : Regulatory / Consulting
Location : Bengaluru, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December 2024
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