Brian Burke-Green
Associate Director Regulatory Submissions at Eyepoint
Based in Washington, United States
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Seniority
Director
Department
Legal
Location
Washington
Industry
Biotechnology Research
Company size
263
Contact information
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b•••••••@eyepoint.bio
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Background
About Brian Burke-Green
Dedicated and highly motivated Global Regulatory Submission professional with extensive experience in regulatory affairs, project management, dossier execution and regulatory requirements and guidelines. Broad experience across US and ex-US markets in preparing and submitting e-CTD packages to the FDA, Health Canada, EMA, and various Latin American Health Authorities. Proven ability to drive projects from inception to execution, whilst balancing competing deadlines. Demonstrated expertise in navigating the complex landscape of regulatory compliance. Leverages regulatory planning and execution of submission activities knowledge, including INDs and amendments, BLAs/NDAs and subsequent reporting, along with communication and analytical skills, to deliver standard operating procedures and process improvements, that provide constancy and meet regulatory requirements. Excels independently, and as part of a team, in fast-paced environments.
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