Regulatory Affairs Manager

Full time
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Job Details

Employment Type

Full time

Salary

0.00 USD

Valid Through

Aug 20, 2025

Job Description

Your area of ?responsibility includes the following activities: Coordination and control of the implementation of change control procedures as well as analysis of the timely processing and implementation of changes路Taking over the project management within the framework of the commissioning of regulatory CROs:

organisation of tenders as well as cooperation in the preparation of the offer and the selection process路Creation and renewal of contracts with CROs and external partners路Carrying out compliance checks and monitoring the budget路Analysis of data on the performance of ECCs using suitable tools to record the implementation status and KPI fulfilment and their controlYour profile Completed scientific studies, preferably pharmacy, chemistry, or biology路Several years of professional experience in the field of project management or approval of medicinal products路Knowledge of the processes in the regulatory environment and the requirements of the LCM activities are desirable路Very good knowledge of German and English, another foreign language is an advantage路Experienced handling of MS Office applications路An analytical and structured way of working with a strong understanding of numbers路Very good organisational skills and the ability to work in a team round off your profile

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