Senior Global Regulatory Scientist

Icon Plc; Johannesburg; On-site; ZAR 50,000 - 70,000; Full time

Job summary

ICON plc is seeking a Senior Global Regulatory Affairs Specialist to play a pivotal role in designing and analyzing clinical trials. You will coordinate regulatory submissions, ensure adherence to timelines, and contribute to innovative treatments. The position requires a Bachelor's degree in a scientific field and 5 years of regulatory affairs experience.

Benefits

Health insurance options

Various annual leave entitlements

Retirement planning options

Global Employee Assistance Programme

Life assurance

Qualifications

• Minimum of 5 years of experience in regulatory affairs in pharma or biotech.
• Strong understanding of global regulatory requirements.
• Excellent communication skills in English.

Responsibilities

• Coordinate IEC and regulatory submissions to meet timelines.
• Provide project-level regulatory information to the Project Team.
• Prepare and perform QC on Clinical Trial Application content.

Skills

Regulatory Affairs

Communication

Analytical Skills

Team Collaboration

Education

Bachelor's degree in a scientific discipline

Job description

Senior Global Regulatory Affairs Specialist at ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, and we invite you to join us in shaping the future of clinical development.

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

Role Overview

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

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

Candidate 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 Offers

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options for you and your family
• Retirement planning options
• Global Employee Assistance Programme, TELUS Health, offering 24-hour support
• Life assurance
• Flexible country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

ICON is committed to diversity, inclusion, and belonging, fostering an environment free of discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.