Global Regulatory Affairs Specialist — Lead Global Submissions

Placements24; Gauteng; Remote; ZAR 900,000 - 1,400,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to oversee global regulatory submissions (CTA) and coordinate strategies across Phase 1–4 clinical trials. You will lead discussions with sponsors and regulatory agencies, and ensure compliant documentation.

As part of the Reg Science team, you will provide regulatory intelligence, liaise with internal stakeholders, and drive meetings with clients and agencies.

Qualifications

• Bachelor's degree or higher.
• 8+ years experience in global clinical trials.
• Knowledge of the global clinical trials landscape.

Responsibilities

• Lead discussions and coordinate regulatory strategies globally on Phase 1–4 trials.
• Provide regulatory intelligence and guidance within the Reg Science team.
• Arrange, lead and report on client and regulatory agency meetings.

Skills

Regulatory submissions

Sponsor liaison

Clinical trial docs

Literature review

Project coordination

Bid defense meetings

Education

Bachelor's degree or higher

Job description

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to oversee global regulatory submissions (CTA) and coordinate strategies across Phase 1–4 clinical trials. You will lead discussions with sponsors and regulatory agencies, and ensure compliant documentation.

As part of the Reg Science team, you will provide regulatory intelligence, liaise with internal stakeholders, and drive meetings with clients and agencies.