Regulatory Submissions Specialist — NL (Hybrid)

Syneos Health Netherlands B.V.; Netherlands; Hybrid; EUR 55,000 - 90,000; Full time

Job summary

Syneos Health Netherlands B.V. is seeking a Submission Specialist for The Netherlands in a hybrid role with 2–3 days per week in Hoofddorp.

You will ensure quality deliverables, follow country regulations, and monitor submission timelines within the SSU framework. The role requires a Bachelor’s degree with strong knowledge of clinical trial processes and start-up activities, plus fluency in Dutch and English.

Qualifications

• Bachelor’s Degree, Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start-up processes.
• Ability to manage external vendors to contract effectively.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Ability to manage multiple project budgets with increased complexity and value.
• Quality-driven in all managed activities.
• Fluency in Dutch and English.

Responsibilities

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities submissions.
• Oversee site activation end to end process at country/site level.
• May act as liaison between investigational sites and functional leads.
• Provides input to local SOPs and WI; supports training materials on local legislation.

Skills

Fluency in Dutch and English

Strong organizational skills

Strong written and verbal沟通能力

Education

Bachelor’s Degree, clinical trial process (PhII-IV & ICH GCP)

Job description

Syneos Health Netherlands B.V. is seeking a Submission Specialist for The Netherlands in a hybrid role with 2–3 days per week in Hoofddorp.

You will ensure quality deliverables, follow country regulations, and monitor submission timelines within the SSU framework. The role requires a Bachelor’s degree with strong knowledge of clinical trial processes and start-up activities, plus fluency in Dutch and English.