Principal Regulatory Affairs Specialist – Global Clinical Trials

About the role

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies for clinical trial applications across Phase 1‑4 studies. You will work within the Reg Science team, providing expert guidance to internal and external stakeholders.

Key responsibilities

• Lead and coordinate regulatory strategies for assigned global clinical trials.
• Prepare, assemble, and submit Clinical Trial Applications (CTA) worldwide.
• Interact with sponsors and regulatory agencies, reviewing and assessing trial documents and scientific literature.
• Manage project teams, participate in launch, review, and project meetings.
• Represent the regulatory department in business development initiatives and quality improvement activities.
• Organise, lead, and report on client and regulatory agency meetings.

Required profile

• Bachelor’s degree or advanced degree preferred, or equivalent qualification.
• Minimum 8 years of experience in global clinical trial regulatory affairs.
• Strong knowledge of the global clinical trials landscape.
• Excellent written and oral English; additional local language as applicable.
• Experience with bid‑defense meetings and leading regulatory projects.
• High attention to detail and commitment to quality.

Required skills

• Preparation and assembly of global regulatory submissions (CTA).
• Review and assessment of clinical trial regulatory documents and scientific literature.
• Project team management and coordination.
• Bid‑defense meeting participation.

What we offer

• Opportunity to work on cutting‑edge clinical research across 100+ countries.
• Collaborative global team environment.
• Resources to support career development and scientific impact.