Senior Regulatory Affairs & Trial Transparency Lead – EMEA

ThermoFisher Scientific; Brussel Hoofdstad; On-site; EUR 70,000 - 110,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Regulatory Affairs Specialist to lead global transparency efforts including protocol registration, result posting, and CTIS redaction, while guiding regulatory strategies across preclinical to registration stages. You’ll interact with clients and internal teams to ensure compliant, timely deliverables.

The role requires strong English communication, 5+ years in clinical trials and 3+ years in transparency, with knowledge of ICH guidelines and global

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years of experience in clinical trials.
• 3+ years of experience in a transparency position (protocol registration, CTIS redaction, clinicaltrials.gov).
• Experience in global/regional/national regulatory requirements and ICH guidelines.
• Familiarity with clinical trial documents and development design.

Responsibilities

• Manage global disclosure and transparency deliverables per policy.
• Register clinical trials in global registries (ClinicalTrials.gov, CTIS).
• Coordinate result postings across registries.
• Oversee redaction of CTIS documents to protect confidential information.
• Maintain knowledge of evolving transparency regulations.
• Provide support and lead transparency activities per direction.
• Prepare and review regulatory submissions.
• Advise clients on regulatory strategy and compliance.

Skills

Regulatory affairs

CTIS knowledge

Clinical trials knowledge

English proficiency

Project coordination

Editorial/proofreading

MS Office

Team leadership

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Word

Excel

PowerPoint

CTIS platform

Job description

Thermo Fisher Scientific is seeking a Senior Regulatory Affairs Specialist to lead global transparency efforts including protocol registration, result posting, and CTIS redaction, while guiding regulatory strategies across preclinical to registration stages. You’ll interact with clients and internal teams to ensure compliant, timely deliverables.

The role requires strong English communication, 5+ years in clinical trials and 3+ years in transparency, with knowledge of ICH guidelines and global