Regulatory Submissions Specialist — Netherlands (Hybrid)

Syneos Health, Inc.; Hoofddorp; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

Syneos Health is seeking a Submission specialist to support country-level regulatory submissions in the Netherlands. This hybrid role requires 2–3 days in the Hoofddorp office, with remote work available.

You will ensure timely local EC/RA submissions, maintain TMF documentation, monitor timelines, and liaise with country start-up advisors. Fluent Dutch and English, strong organizational and communication skills are essential.

Qualifications

• Bachelor’s degree in a relevant field.
• Fluency in Dutch and English.
• Experience with regulatory submissions and TMF processes.
• Strong written and verbal communication plus organizational skills.

Responsibilities

• Manage local and central regulatory submissions (EC/RA) for the country.
• Ensure timely submission timelines and maintain SSU tracking records.
• Review and compile essential documents for site activation and regulatory filings.
• Coordinate with CSAs, SAMs and PMs to support start-up activities.
• Maintain TMF quality and documentation, and assist in process improvements.

Skills

Dutch & English fluency

Regulatory submissions

Strong communication

Budget management

Organization

Vendor management

Problem-solving

Education

Bachelor’s Degree

Job description

Syneos Health is seeking a Submission specialist to support country-level regulatory submissions in the Netherlands. This hybrid role requires 2–3 days in the Hoofddorp office, with remote work available.

You will ensure timely local EC/RA submissions, maintain TMF documentation, monitor timelines, and liaise with country start-up advisors. Fluent Dutch and English, strong organizational and communication skills are essential.