Senior Regulatory Scientist
ICON plc
full-time
Posted on:
Location Type: Hybrid
Location: Johannesburg • 🇿🇦 South Africa
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Responsible for completing country and/or regional clinical trial regulatory deliverables in line with study specifics.
- Ensure compliance with ICH-GCP, relevant regulations, and sound scientific principles.
- Contribute to process improvement initiatives, mentor junior staff as needed.
- Provide strategic input into submissions planning.
- Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards.
- Apply advanced knowledge of ICON SOPs/WIs, ICH-GCP, and local regulatory requirements.
- Prepare, adapt, coordinate, and collate submission documentation per study and country requirements.
- Manage internal and external reviews of regulatory documentation.
- Oversee translation management and submission lifecycle through approval.
- Maintain proactive communication with project teams to ensure timely updates on submission and approval status.
- Collaborate cross-functionally to ensure regulatory deliverables are met.
- Support maintenance of up-to-date clinical trial regulatory intelligence across global and regional levels.
- Mentor junior team members and contribute to the ongoing enhancement of ICON’s regulatory processes.
Requirements
- Educated to degree level in life sciences or related discipline.
- Experienced with a minimum of 3 years’ relevant regulatory experience in clinical research.
- Fluent in English and the local country language.
- Highly organized with excellent attention to detail and ability to manage multiple priorities.
- A strong communicator with the ability to engage internal teams and external stakeholders effectively.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsclinical trial regulatory deliverablesICH-GCPICON SOPs/WIssubmission documentationtranslation managementregulatory documentation reviewsclinical researchprocess improvementregulatory intelligence
Soft skills
mentoringcommunicationorganizational skillsattention to detailability to manage multiple prioritiesstrategic inputcollaborationproactive communicationengagement with stakeholdersteamwork