Senior Global Regulatory Affairs Manager – Clinical Trials

Jobgether SRL; Netherlands; On-site; EUR 90,000 - 130,000; Full time

Job summary

Jobgether SRL in the Netherlands seeks a Manager, Regulatory Affairs to lead submissions across international markets, ensuring compliance and strategic guidance throughout the study lifecycle.

You will coordinate regulatory activities, advise sponsors and project teams, and contribute to proposals and budgets in a dynamic clinical research environment, while coaching junior colleagues.

Qualifications

• Bachelor's degree in medical, biological, health, pharmacy or related field.
• At least 8 years clinical research or regulatory affairs experience.
• 5-7 years in pharma/CRO with senior regulatory experience.
• Strong leadership and cross-cultural collaboration.
• Excellent written and verbal English communication.

Responsibilities

• Lead and coordinate regulatory submissions and ethics approvals across EMEA, APAC and LATAM.
• Ensure submissions are accurately prepared, tracked and timely.
• Provide expert regulatory guidance on country-specific and international requirements.
• Review technical documents (IMPDs, IBs) for compliance with ICH GCP and country rules.
• Mentor junior regulatory affairs professionals and support study objectives.

Skills

Leadership

Regulatory affairs

Project coordination

Stakeholder management

English communication

Education

Bachelor's degree in life sciences

Job description

Jobgether SRL in the Netherlands seeks a Manager, Regulatory Affairs to lead submissions across international markets, ensuring compliance and strategic guidance throughout the study lifecycle.

You will coordinate regulatory activities, advise sponsors and project teams, and contribute to proposals and budgets in a dynamic clinical research environment, while coaching junior colleagues.