Principal Regulatory Affairs Specialist

Thermo Fisher Scientific seeks a Principal Regulatory Affairs Specialist in São Paulo to lead regulatory strategy and document review across multiple countries and clinical trial projects. The role involves providing expert regulatory guidance, managing junior staff, and serving as liaison between internal and external clients on complex development initiatives.

Responsibilities

• Review regulatory documents and submissions to ensure compliance with local, regional, and ICH standards
• Provide strategic regulatory guidance to internal and external clients on project development and licensing
• Lead matrix/project activities, mentor junior team members, and provide regulatory training
• Act as primary liaison between clients and internal teams for regulatory service delivery and marketing
• Manage project budgets, timelines, scope adherence, and contribute to business development forecasting

Requirements

• Bachelor's degree or equivalent relevant academic/vocational qualification
• 8+ years of experience in regulatory affairs or related field
• Fluent English (written and oral); local language proficiency preferred
• Expert knowledge of ICH guidelines and global regulatory requirements for clinical trials
• Strong Microsoft Office skills and ability to learn new technologies
• Excellent written communication, attention to detail, and proofreading ability