Regulatory Operations Specialist

Remote – UK

Permanent Position

FSP Opportunity through Advanced Clinical

Advanced Clinical is supporting a global biotech organisation in the search for a Clinical Trial Transparency Anonymisation Specialist to join their growing Clinical Operations / Trial Disclosure team.

This is an excellent opportunity for someone with experience in clinical trial disclosure, transparency, anonymisation, or regulatory document publishing who is looking to work within a highly collaborative global environment.

Key Responsibilities

• Manage anonymisation of clinical trial documents and datasets for public disclosure
• Support EU CTR, ClinicalTrials.gov, EMA Policy 0070, and Health Canada PRCI submissions
• Develop anonymisation strategies and assess re-identification risk in line with GDPR guidance
• Collaborate with Biostatistics, Programming, Medical Writing, and Regulatory Operations teams
• Perform quality review of redacted/anonymised documents
• Support transparency and data‑sharing initiatives globally

Requirements

• Bachelor’s degree in a scientific or technical discipline
• Minimum 3 years’ experience within pharma, biotech, or CRO environments
• Experience with clinical trial transparency/disclosure activities
• Knowledge of EU CTR, EMA Policy 0070, ClinicalTrials.gov, or related regulations
• Understanding of anonymization/redaction methodologies and disclosure processes
• Strong communication and organisational skills
• Experience with document management systems and analytical tools

Fully remote role within the UK with minimal travel requirements.

#J-18808-Ljbffr…