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
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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