Regulatory Affairs Specialist

3 days ago


King of Prussia, Pennsylvania, United States Parexel International Corporation Full time
Parexel Croatia Job Opportunity

We are seeking 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.

Key Responsibilities:
  • Provide leadership in all regulatory and submissions related aspects of the clinical trial
  • Deliver submission specific milestones and provide guidance to the client on submissions strategies
  • Collaborate with departments to ensure transversal collaboration and delivery of all submissions of complex large clinical trials
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 local language
  • Background in clinical trial submissions with a specific focus on EU-CTR
  • Project Management experience

Parexel Croatia is a leading provider of clinical trials services, and we are committed to delivering high-quality solutions to our clients. If you are a motivated and experienced Regulatory Affairs Consultant, we encourage you to apply for this exciting opportunity.



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