Remote Global Regulatory Affairs Lead – CTAs & Trials

Placements24; Klerksdorp; Remote; ZAR 800.000 - 1.200.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Learning & development program

Flexible working culture

Health and well-being benefits

Zusammenfassung

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies for clinical trial applications from Phase 1 to 4. This role involves coordinating with sponsors, internal teams, and regulatory agencies to ensure compliant, timely submissions in a remote, global setting.

The ideal candidate will have 8+ years in regulatory affairs, strong expertise in CTA submissions, and exceptional communication skills in English.

Qualifikationen

• Bachelor's degree or advanced degree preferred, or equivalent
• 8+ years experience in regulatory affairs for clinical trials
• Knowledge of global clinical trials landscape

Aufgaben

• Lead regulatory strategies globally for Phase 1–4 trials
• Coordinate regulatory activities with internal teams and sponsors
• Provide regulatory intelligence and guidance to clients
• Arrange and report on meetings with regulators and clients
• Oversee submission planning and lifecycle management

Kenntnisse

Global regulatory submissions

Sponsor interfacing

Regulatory documents review

Literature review

Project team leadership

Meetings coordination

Bid defense experience

Ausbildung

Bachelor's degree or higher

Jobbeschreibung

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies for clinical trial applications from Phase 1 to 4. This role involves coordinating with sponsors, internal teams, and regulatory agencies to ensure compliant, timely submissions in a remote, global setting.

The ideal candidate will have 8+ years in regulatory affairs, strong expertise in CTA submissions, and exceptional communication skills in English.