Senior Global Regulatory Scientist

Icon Plc; Gauteng; On-site; ZAR 600,000 - 900,000; Full time

Job summary

A leading healthcare intelligence and clinical research organization seeks a Senior Global Regulatory Affairs Specialist to join their team in South Africa. You will play a pivotal role in coordinating regulatory submissions, ensuring compliance with global regulations, and contributing to innovative clinical development. The position offers competitive salary and a range of benefits, including health insurance and retirement planning. Join ICON to help shape the future of clinical research.

Benefits

Various annual leave entitlements

Health insurance options

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Flexible country-specific benefits

Qualifications

• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of global regulatory requirements and guidelines.
• Excellent communication skills in English.

Responsibilities

• Coordinate all Central Independent Ethics Committee and Regulatory Agency submissions.
• Provide the Sponsor and Project Team with information on regulations governing clinical trials.
• Prepare the Core Clinical Trial Application and perform quality control on submission packages.

Skills

Regulatory Affairs

Communication

Team Collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Senior Global Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization.

We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Global Regulatory Affairs Specialist to join our diverse and dynamic team.

As a Senior Global Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Responsibilities:

• Coordinate all Central Independent Ethics Committee (IEC), Regulatory Agency (RA), and other central authority submissions to ensure adherence to contractual timelines.
• Communicate submission status updates to the Start-Up Lead (SUL) and collaborate to mitigate risks to Sponsor deliverables.
• Provide the Sponsor and internal Project Team with information on regulations governing the clinical trial at a project level.
• Address Sponsor queries related to regulatory and submission requirements.
• Prepare the Core Clinical Trial Application and perform quality control (QC) on the content of all central submission packages.
• Support Business Development efforts by contributing regulatory input for Requests for Proposal (RFPs), Requests for Information (RFIs), and participation in Bid Defense Meetings.

Your profile:

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Strong understanding of global regulatory requirements and guidelines.
• Excellent communication skills in English.
• Ability to work independently and collaboratively in a fast-paced environment.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits, including:

• Various annual leave entitlements.
• A range of health insurance options to suit you and your family's needs.
• Retirement planning offerings to maximize savings.
• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to support services.
• Life assurance.
• Flexible country-specific benefits like childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, and more.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, helping us serve our people, patients, customers, and communities better.

We are committed to providing an inclusive and accessible environment for all candidates and a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you need a reasonable accommodation during the application process or to perform the essential functions of the role, please let us know or submit a request here.

Interested in the role but unsure if you meet all requirements? We encourage you to apply regardless — you might be exactly what we're looking for, whether for this or other roles.

If you're a current ICON employee, please click here to apply.

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