Sr Reg Affairs Spec - Regulatory Liaison

Thermo Fisher Scientific seeks a Senior Regulatory Affairs Specialist to provide regulatory guidance and manage submission activities. The role involves liaising with internal teams and health authorities while overseeing regulatory document assessment and global submission preparation.

Responsibilities

• Assess regulatory documents and prepare global regulatory submissions
• Serve as liaison between Regulatory Affairs Department and project teams
• Interface with health authorities regarding regulatory strategy and submissions
• Conduct QC review of final submission packages
• Direct project teams on regulatory strategy and submission responsibilities

Requirements

• Bachelor's degree; Pharmacy or Life Science degree preferred
• Previous regulatory affairs experience or equivalent relevant work experience
• Knowledge of regulatory requirements, timelines, and global application processes
• Experience with clinical trial applications in EU and other regions
• Excellent English communication skills, both written and verbal
• Proficiency with Microsoft Office and clinical trial systems (eTMF, CTMS)
• Strong organizational, planning, and problem-solving abilities