Senior Regulatory Affairs & Trial Transparency Lead – EMEA

ThermoFisher Scientific; Nederland; Hybrid; EUR 85,000 - 118,000; Full time

Job summary

Thermo Fisher Scientific in the Netherlands is seeking a Senior Regulatory Affairs Specialist to drive global trial transparency activities, CTIS registrations, and regulatory submissions across regions.

You will advise clients, lead redaction efforts, and collaborate with colleagues to ensure compliance with ICH and local regulations, with opportunities to mentor juniors and influence product development timelines.

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• 5+ years of experience in regulatory affairs, preferably in clinical trials.
• 3+ years of experience in clinical trials, with CTIS/registration knowledge a plus.
• Experience understanding global regulatory guidelines (ICH, etc.).

Responsibilities

• Lead global CTI transparency activities, including protocol registration and result posting.
• Coordinate redaction of CTIS documents and identify confidential information.
• Prepare regulatory submissions and provide strategy to clients.
• Collaborate with internal teams and external authorities to ensure compliance.
• Mentor junior staff and participate in project launches.

Skills

Regulatory affairs

English communication

Attention to detail

Editorial/proofreading

Team collaboration

Microsoft Office

Project coordination

Analytical thinking

Education

Bachelor's degree or equivalent

Tools

Adobe Acrobat Pro

Job description

Thermo Fisher Scientific in the Netherlands is seeking a Senior Regulatory Affairs Specialist to drive global trial transparency activities, CTIS registrations, and regulatory submissions across regions.

You will advise clients, lead redaction efforts, and collaborate with colleagues to ensure compliance with ICH and local regulations, with opportunities to mentor juniors and influence product development timelines.