* Trial start-up
* CEC and CA submissions
For one of its clients, Hays Life Sciences is Recruiting a Clinical Regulatory Specialist with at least three years of experience in Site Activation Regulatory operations completing CEC and CA submissions.
As a Site Activation Specialist, you will manage the preparation, review and coordination of Country Submissions (MoH, EC and additional special national local applications) in line with global submission strategy. You will provide, under guidance, local regulatory strategy advice (MoH &/or EC) to internal clients and will provide project specific local SIA services and coordination of these projects. You may have contact with investigators for submission related activities and will play a key-contact role at country level for either Ethical or Regulatory submission-related activities. You will coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. As a Site Activation Specialist, you will support the coordination of feasibility activities, enter and maintain trial status information relating to SIA activities onto tracking databases in an accurate and timely manner. You will ensure the local country study files and filing processes are prepared, set up and maintained.
You have at least 3 years' experience within the Clinical Regulatory field. You are experienced in the completion of CA submissions and interaction with Competent Authorities. You have good negotiation skills, strong attention to detail and quality of documentation. You are knowledgeable in applicable regional / national country regulatory guidelines and EC regulations. You have basic medical/therapeutic area and medical terminology knowledge and excellent English language and grammar skills, French and Dutch fluency is an asset.
We offer you this interesting operational position in consultancy, open for both professionals working under employee or freelance status.
Interested in this role? Do not hesitate to apply! For more information, please contact Kateryna Hamandiy, Hays Life Sciences Consultant at 010 233 866.