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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

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Principal Regulatory Affairs Specialist (Global Clinical Trial Applications)

Job Description

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We are currently seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs department, Reg Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.
In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.
You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.
You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.
You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.
The following skills are required to be successful in this position:

• preparation and assembly of global regulatory submissions (CTA)
• interacting with sponsors,
• review and assess clinical trial regulatory documents,
• review and assess scientific literature.
• manages project teams and preparation
• participate in launch meetings, review meetings and project team meetings.
• Experience with bid defense meetings

Qualifications
What the role requires you to have:

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years
• Knowledge of the global clinical trials landscape

Knowledge, Skills and Abilities:

• Excellent command of the English language (written and oral) as well as local language where applicable
• Experience with Bid Defense meetings