Regulatory Submissions Manager

I am currently working with a full-service clinical contract research organisation (CRO) that provide phase 1-4 clinical development services to the biotechnology, pharmaceutical and medical devices industries.

Their clinical operations activities are growing rapidly so they are currently seeking a fulltime office-based Regulatory Submissions Manager to join the team. This position will work a team to accomplish tasks and projects that are instrumental to the company's success. if you are an experience individual that want an exciting career where you use your previous expertise, then this is the opportunity for you.

Responsibilities

• Efficiently manage and successfully execute all aspects of global start-up;
• Perform quality checks on submission documents and site essential documents;
• Prepare and approve informed consent forms;
• Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
• Present during bid defences, general capabilities meetings, and audits.
  
  Qualifications
  
  
  
• At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
• Knowledge and experience of Clinical Trial Applications within Europe;
• Strong oral and written communication skills;
• Team oriented approach and strong leadership skills; and
• Fluency in English

If you are interested then please apply below or give Claire Kiwanuka from NonStop Consulting a call to find out more!