Regulatory Affairs Manager (Global Clinical Trial Applications)

About the role

Thermo Fisher Scientific is seeking a Regulatory Affairs Manager to lead global regulatory submissions for clinical trial applications across Phase 1‑4 studies. The position sits within the senior individual contributor framework of the Regulatory Science team, providing strategic regulatory guidance to internal and external clients.

Key responsibilities

• Lead the preparation and submission of global Clinical Trial Applications (CTA) ensuring compliance with local and regional requirements.
• Act as subject‑matter expert, delivering regulatory strategy advice and technical expertise for moderate to high‑complexity projects.
• Provide oversight across multiple studies, aligning regulatory strategy, quality, and delivery.
• Serve as senior client‑facing lead, contributing to proposals, bid defenses, and scope discussions.
• Manage project budgeting, forecasting, and financial accountability.
• Identify out‑of‑scope activities and coordinate contract modifications with relevant teams.
• Collaborate with business development on pricing, proposals, and client presentations.
• Provide matrix and project leadership to team members.
• Ensure compliance with organizational SOPs and regulatory work product documents.
• Participate in launch, review, and project team meetings.

Required profile

• Bachelor’s degree or advanced degree preferred, or equivalent relevant qualification.
• Minimum 9 years of experience in regulatory affairs within global clinical trial settings.
• Proven project management experience across multiple concurrent studies.
• Demonstrated ability to engage senior clients and lead cross‑functional teams.
• Strong financial and scope management capabilities.

Required skills