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Regulatory Affairs Specialist

4 weeks ago

King of Prussia, Pennsylvania, United States PAREXEL Full time
Parexel Croatia is seeking an experienced Regulatory Affairs Specialist to provide operational and business clinical trials regulatory consultancy to clients. The ideal candidate will possess a university degree in a life science discipline, significant CRO/Pharma experience within Regulatory, and fluency in English and the local language. Key responsibilities include providing leadership in all regulatory and submissions related aspects of the clinical trial, coordinating large and complex clinical trial submissions in EU and other countries, and ensuring transversal collaboration between departments. The successful candidate will have solid analysis and synthesis capability, solution-oriented and problem-solving skills, and a background in clinical trial submissions with a specific focus on EU-CTR.

Key Responsibilities:

* Provide operational and business clinical trials regulatory consultancy to clients
* Coordinate large and complex clinical trial submissions in EU and other countries
* Ensure transversal collaboration between departments
* Provide leadership in all regulatory and submissions related aspects of the clinical trial
* Deliver submission specific milestones
* Provide guidance to the client on submissions strategies

Requirements:

* 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 and the local language
* Background in clinical trial submissions with a specific focus on EU-CTR
* Project Management experience

Parexel Croatia offers a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs Specialist, please submit your application.