Remote Regulatory Affairs Lead — Global Trials

Placements24; South Africa; À distance; ZAR 700 000 - 1 300 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks a Principal Regulatory Affairs Specialist to lead global regulatory submissions for clinical trials, coordinating with sponsors and agencies across multiple regions. The role focuses on ensuring compliance of CTAs, MAAs, and related documents while guiding internal teams on regulatory strategy.

Remote work with global scope is possible. You will drive submission initiatives, manage project teams, and participate in regulatory agency meetings to accelerate product

Qualifications

• Bachelor's or advanced degree in a relevant field or equivalent formal qualification.
• 8+ years' experience in global regulatory affairs for clinical trials.
• Knowledge of ICH/global regulatory guidelines and CTAs/MAA submissions.

Responsabilités

• Lead/global regulatory submissions for Phase 1–4 trials (CTA/MAA/NDA).
• Coordinate with sponsors and regulatory agencies; provide guidance.
• Review regulatory documents and literature; ensure compliance.
• Participate in launch and project meetings; lead defense discussions.

Connaissances

global regulatory submissions

sponsor interaction

regulatory document review

literature review

Formation

Bachelor's or advanced degree

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

Thermo Fisher Scientific seeks a Principal Regulatory Affairs Specialist to lead global regulatory submissions for clinical trials, coordinating with sponsors and agencies across multiple regions. The role focuses on ensuring compliance of CTAs, MAAs, and related documents while guiding internal teams on regulatory strategy.

Remote work with global scope is possible. You will drive submission initiatives, manage project teams, and participate in regulatory agency meetings to accelerate product