Senior Global Regulatory Scientist

1 week ago

Johannesburg, South Africa ICON Plc Full time

Senior Global Regulatory Scientist

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

Senior Global Regulatory Scientist

South Africa, UK, Ireland, Poland, Office or homebased

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.

Key Responsibilities
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

Qualifications and Experience
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

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