Regulatory Affairs Consultant - CTA /EU-CTR
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About The Position
Parexel Croatia is seeking an experienced Regulatory Affairs Consultant to join our team in King of Prussia, Pennsylvania. This role is pivotal in providing operational and business clinical trials regulatory consultancy to our clients, particularly in relation to the new EU Clinical Trials Regulation (EU CTR). As a Regulatory Affairs Consultant, you will coordinate large and complex clinical trial submissions not only in the EU but also across various countries globally. Your expertise will be essential in navigating the regulatory landscape and ensuring compliance with the latest regulations. In this position, you will take on a leadership role in all regulatory and submission-related aspects of clinical trials. You will serve as the primary contact for clients, responsible for delivering submission-specific milestones and providing strategic guidance on submission strategies. Your involvement will extend to EU CTR consulting and the operational aspects of implementing these regulations. As the Clinical Trial Submission Coordinator, you will ensure effective collaboration across departments, working diligently towards the successful delivery of submissions for complex large clinical trials. The ideal candidate for this role will possess a university degree in a life science discipline and have significant experience within a Contract Research Organization (CRO) or pharmaceutical company, specifically in regulatory affairs. You should demonstrate strong analytical and synthesis capabilities, along with solution-oriented and problem-solving skills. Fluency in English is essential, and proficiency in the local language is also required. A solid background in clinical trial submissions, particularly with a focus on EU-CTR, and project management experience will be critical for success in this role.
