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Regulatory Affairs Associate

Do you have the passion and skills to successful execute oncology clinical trials by supporting the regulatory affairs team in execution of regulatory (start-up) activities related to clinical projects? Do you like to support in creation and submission of clinical trial documents and ICF’s within specific timelines? Are you interested in the international regulatory landscape and like contribute to collection, interpretation, analysis of accurate regulatory and start-up intelligence? Do you flourish liaising with internal departments and external parties?

Who?

A highly organized proactive professional with an eye for detail and with the ambition to work in an oncology dedicated high performance organization. Somebody with the passion for regulatory affairs to support the management of oncology clinical projects.

You:

  • Life science, healthcare and/or business degree
  • Minimum 1 year of relevant work experience in start-up requirements, activities, submissions to and approval of CA, EC and site
  • Minimum 1 year of experience in cancer research
  • Knowledge of ICH-GCP and applicable regulatory requirements
  • Fluent in written and spoken English 
  • Representative, outgoing and client focused
  • Ability to work in a fast-paced, challenging environment within a growing company
  • Administrative excellence 

The department:

You will be part of SMS-oncology’s Regulatory Affairs team that offer full support with respect to regulatory affairs and activities in the regulatory landscape.

SMS-oncology:

SMS-oncology is one of the few CROs in the world solely dedicated to oncology. With our unique business model of integrating oncology drug development affairs and clinical operations, we cover the whole value chain from trial design to the setup, management and completion of phase I to IV oncology trials. We specialize in early phase, pediatric and immuno-oncology trials. Our goal is to be the leading oncology CRO. We believe that oncology trials require oncology experts. Our clients can rely on our expertise and our proactive, responsive and pragmatic approach. Our mission is to excel in oncology trials for the benefit of our clients and cancer patients worldwide. SMS-oncology nurtures a high performance culture, provides continuous training, offer unique opportunities to learn, and stimulates personal and organizational development. Our high performance culture impacts our retention rate positively, as represented by our industry leading rate of ~95%.

What can SMS-oncology offer you?

  • A possibility to contribute to the development of innovative cancer therapies that will benefit patients and their families
  • A fast growing and dynamic environment
  • Exciting opportunities to further develop yourself in becoming an autonomous, flexible oncology expert

Interested?

Call our recruitment team via + 31 (0)20 4350 580 or send an e-mail to recruitment@sms-oncology.com.

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