Senior Regulatory Affairs Leader – Global Trials & Strategy

ThermoFisher Scientific; Comisión de Fomento de Perú; Hybrid; ARS 136,430,000 - 227,383,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy across multiple countries and projects from preclinical through registration and optimization. You will provide strategic regulatory intelligence, client interface, and ensure compliant deliverables aligned with ICH and regional requirements.

The role requires broad experience, strong English communication, attention to detail, and the ability to mentor junior staff while coordinating with

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification
• 8+ years of applicable experience in regulatory affairs
• Strong knowledge of global/regional/national regulatory requirements and ICH guidelines

Responsibilities

• Lead senior review of regulatory documents to ensure high quality standards meeting client and regulatory requirements.
• Provide regulatory strategy advice to internal and external clients on projects of moderate complexity.
• Support project management activities and liaise with clients to market regulatory services.
• Provide mentorship and guidance to junior team members to ensure understanding of regulations and timely deliverables.
• Ensure adherence to budgets, timelines, and scope of work.
• Support business development through budgeting/forecasting input.

Skills

Regulatory strategy

Document review

Project management

Stakeholder liaison

Budgeting/forecasting

English communication

ICH/regulatory knowledge

Team mentoring

Education

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

Job description

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategy across multiple countries and projects from preclinical through registration and optimization. You will provide strategic regulatory intelligence, client interface, and ensure compliant deliverables aligned with ICH and regional requirements.

The role requires broad experience, strong English communication, attention to detail, and the ability to mentor junior staff while coordinating with