Country Approval Specialist – Netherlands in Netherlands

Do you have experience managing, preparing, reviewing and coordinating regulatory country submissions in the Netherlands? If so, this position could be for you!

We are recruiting for a Country Approval Specialist based in the Netherlands to work for a globally leading CRO.

This position is offered on a contract basis for 3 months initially, working 20 hours per week.

Responsibilities:

• Prepare, review and coordinate, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy
• Provide, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
• Provide project specific local SIA services and coordination of these projects
• May have contact with investigators for submission related activities
• Key-contact at country level for either Ethical or Regulatory submission-related activities
• Coordinates, under guidance, 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
• May work with the start-up CRAsto prepare the regulatory compliance review packages, as applicable
• May develop country specific Patient Information Sheet/Informed Consent form documents
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines
• Enter and maintain trial status information relating to SIA activities ontotracking databases in an accurate and timely manner
• Ensure the local country study files and filing processes are prepared, set up and maintained as perWPDs or applicable client SOPs

Education:

• Bachelor's degree in relevant scientific subject

Skills experience:

• Knowledge of all applicable regional / national country regulatory guidelines and EC regulations
• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required