Local Submissions Specialist - Regulatory (Netherlands)

Syneos Health, Inc.; Netherlands; Hybrid; EUR 44,000 - 62,000; Full time

Job summary

Syneos Health in the Netherlands seeks a Submission Specialist to manage country-level regulatory submissions and site activation for sponsor partnerships. The role is hybrid, with 2–3 days per week in the Hoofddorp office, focusing on EC/RA submissions, document packages, and quality control across the country.

The ideal candidate holds a Bachelor's degree, has in-depth knowledge of clinical trial processes, and demonstrates strong organizational, budget, and communication skills, fluent in

Qualifications

• Bachelor’s Degree required.
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and study specifications.
• Detailed understanding of clinical trial start-up processes.
• Ability to manage external vendors to contract effectively.
• Quality-driven in all managed activities.

Responsibilities

• Ensure quality deliverables at the country level; follow project requirements and country rules with oversight; monitor timelines and track milestones.
• Monitor basic financial aspects of the project and hours/tasks; escalate discrepancies.
• Review SOPs and WI; keep training records updated and ensure timesheet compliance.
• Support continuous improvement of Site Start-Up components at country level (submissions, documents, communications to authorities).
• Prepare and submit regulatory applications (Central/Local EC, RA) and other local submissions within country; manage safety notifications when required.
• Liaise between sites and leads; oversee site activation end-to-end.
• Act as country start-up advisor; provide input on SOPs/WI; support data protection statements.

Skills

Fluency in Dutch

Fluency in English

Strong organizational skills

Budget management

Communication skills

Problem solving

Education

Bachelor’s Degree

Job description

Syneos Health in the Netherlands seeks a Submission Specialist to manage country-level regulatory submissions and site activation for sponsor partnerships. The role is hybrid, with 2–3 days per week in the Hoofddorp office, focusing on EC/RA submissions, document packages, and quality control across the country.

The ideal candidate holds a Bachelor's degree, has in-depth knowledge of clinical trial processes, and demonstrates strong organizational, budget, and communication skills, fluent in