Senior Global Regulatory Scientist
ICON plc
full-time
Posted on:
Location Type: Hybrid
Location: Johannesburg • 🇿🇦 South Africa
Visit company websiteJob Level
Senior
About the role
- Provide expert regulatory advice throughout clinical development and product lifecycle activities
- Develop high quality regulatory strategies and author regulatory documentation including clinical and nonclinical sections of submissions
- Lead or contribute to meetings and correspondence with regulatory agencies
- Support global submission planning and execution across multiple markets
- Advise internal and external partners on evolving regulatory expectations and best practices
- Collaborate with cross functional teams to ensure alignment of regulatory plans with clinical and commercial objectives
- Contribute to continuous improvement of regulatory processes within ICON
Requirements
- Advanced degree in a scientific or related discipline
- Significant regulatory experience within pharmaceutical, biotechnology or Clinical Research Organisation settings
- Proven experience supporting global submissions and health authority interactions
- Strong understanding of regional and international regulatory guidelines
- Exceptional communication skills with the ability to translate complex requirements into clear guidance
- Demonstrated ability to manage multiple priorities in a fast paced environment
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 strategiesregulatory documentationclinical submissionsnonclinical submissionsglobal submission planningregulatory processes
Soft skills
communication skillscollaborationability to manage multiple priorities
Certifications
advanced degree