Remote Principal Regulatory Affairs Specialist Global CTAs

Alignerr Corp.; South Africa; Hybride; ZAR 2 326 000 - 3 490 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Extensive benefits package

Flexible working culture

Global team

Résumé du poste

Thermo Fisher Scientific seeks a Principal Regulatory Affairs Specialist to drive global regulatory submissions and strategies for Clinical Trial Applications. You will coordinate cross‑functional teams, lead pivotal regulatory discussions with sponsors, and provide expert regulatory guidance across multiple trial phases.

The role emphasizes leadership in global regulatory projects, strong English communication, and collaboration with internal and external stakeholders in a remote setting.

Qualifications

• Bachelor's degree or advanced degree in a relevant field; or equivalent formal qualification.
• 8+ years of experience in regulatory affairs or related field.
• Knowledge of the global clinical trials landscape and regulatory requirements.

Responsabilités

• Lead global regulatory strategies for Clinical Trial Applications across Phase 1–4.
• Coordinate regulatory activities and meetings with clients and agencies.
• Provide regulatory intelligence and guidance to internal stakeholders.

Connaissances

CTA submissions

Sponsor interaction

Regulatory reviews

Bid Defense

Project leadership

Global trials

Regulatory strategy

Team coordination

Formation

Bachelor's degree or higher

Advanced degree preferred

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Thermo Fisher Scientific seeks a Principal Regulatory Affairs Specialist to drive global regulatory submissions and strategies for Clinical Trial Applications. You will coordinate cross‑functional teams, lead pivotal regulatory discussions with sponsors, and provide expert regulatory guidance across multiple trial phases.

The role emphasizes leadership in global regulatory projects, strong English communication, and collaboration with internal and external stakeholders in a remote setting.