Regulatory Affairs Consultant - CTA /EU-CTR
Parexel International Corporation, King of Prussia, PA, United States
Parexel Croatia is currently looking for an experienced Regulatory Affairs Consultant to provide operational and business clinical trials regulatory consultancy to clients, including new EU CTR regulations and to coordinate large and complex clinical trial submissions in EU and other countries across the globe.
In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies. You will be involved in EU CTR consulting and in operational aspects of EU CTR implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.
Ideal candidate will possess:
University degree in life science discipline
Significant CRO/Pharma experience within Regulatory
Solid analysis and synthesis capability; Solution-oriented and problem-solving skills
Fluency in English is a must along with the local language
A background in clinical trial submissions with a specific focus on EU-CTR
Project Management experience
Fluent English and local language