EMEA Senior Regulatory & Trial Transparency Lead

ThermoFisher Scientific; United Kingdom; Remote; GBP 70,000 - 95,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Regulatory Affairs Specialist to lead strategic regulatory intelligence and guidance from preclinical stages through registration and optimization. You will collaborate with clients to deliver compliant, efficient, and innovative regulatory deliverables across regions, ensuring adherence to ICH and global guidelines.

The role includes leading transparency activities, protocol registrations, CTIS redactions, and post-marketing considerations, while

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years of experience in regulatory/clinical trials or equivalent.
• 3+ years in clinical trials with transparency experience (protocol registration, CTIS redaction, clinicaltrials.gov) is a plus.

Responsibilities

• Coordinate global disclosure and transparency deliverables in line with policy.
• Register clinical trials in global registries (ClinicalTrials.gov, CTIS).
• Lead and coordinate result postings in global registries.
• Manage redactions of CTIS documents and identify confidential information.
• Maintain knowledge of evolving transparency regulations and provide guidance.
• Prepare regulatory submissions and provide regulatory strategy to clients.

Skills

Strong English

Editorial/proofreading

Interpersonal skills

Independent judgement

Team player

Leadership skills

Time management

Negotiation skills

Education

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat Pro

Job description

Thermo Fisher Scientific is seeking a Senior Regulatory Affairs Specialist to lead strategic regulatory intelligence and guidance from preclinical stages through registration and optimization. You will collaborate with clients to deliver compliant, efficient, and innovative regulatory deliverables across regions, ensuring adherence to ICH and global guidelines.

The role includes leading transparency activities, protocol registrations, CTIS redactions, and post-marketing considerations, while