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Regulatory Affairs Associate (MAA) French speaking
Parexel International Corporation
Bucharest, București, Romania
A Regulatory Affairs Associate must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services Parexel Consulting provides. A Regulatory Affairs Associate must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. A Regulatory Affairs Associate ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Senior Regulatory Affairs Associate assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
We are currently looking for a Regulatory Affairs Associate who will have the following responsibilities:
• Preparation of EU submissions packages (LCM activities - variations, renewals, etc.)
• Change Control assessment
• Provide regulatory support and perform regulatory activities within emerging markets team. This will include meetings between client, local contacts & the distributors, performing day to day regulatory activities relating to labelling, type I, type II variations, NDAs / MAA applications, updating trackers, coordinating activities with distributors/affiliates and client.
• Provide regulatory intelligence support and preparing summaries of the updates in daily/weekly newsletters.Qualifications• Good understanding of performing the above regulatory tasks on a regional/global level
• Few years of experience in regulatory Affairs (LCM)
• Good project Management skills
• Proactive approach and good communication skills
• Fluent English and Romanian
Job posted: 2020-10-06