Brian Burke-Green
Global Regulatory Submission Management Professional | Regulatory Operations & Process Innovation Specialist | e-CTD expert
- Role
- Associate Director Regulatory Submissions at EyePoint
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
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.
Experience
Associate Director Regulatory Submissions
May 2024 — Present · Watertown, MA, US
Collaborate with Regulatory Project Leads to develop submission plans and enhance regulatory systems. Drive submission coordination activities, maintaining content trackers, and ensuring up-to-date deliverables. Conduct final review and approval on eCTD documents for health authority submissions. Provide guidance and oversight to publishing and submission teams and ensure department is current with US and international regulatory guidance.
Education
Temple University
BS, Biology
2007 — 2009
Howard University
Biology/ Pre Pharmacy
2003 — 2006
St. John's University
M. Sc., Pharmaceutical Regulatory Affairs/ Quality Assurance
2010 — 2013
Skills
- Regulatory Submissions
- Anda
- Ctd
- Cgmp Practices
- Cgmp Manufacturing
- Generic Drug Regulation
- Regulations
- Regulatory Affairs
- Quality Assurance
- Gmp
- Medical Devices
- Glp
- Validation
- Fda
- Pharmaceutical Industry
- Clinical Development
- Pharmaceutics
- Regulatory Requirements
- Iso 13485
- Microsoft Office
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