Anusha Gopalakrishnan Email & Phone Number

Seattle

Greater Seattle Area

• Prepare regulatory documentation for IRB approval and the clinical trial sites in compliance with FDA regulations
• Write and maintain SOPs and cGMP for the project with feedback from the development team
• Research and implement requirements for clinical trials and submission approval in US and other countries
• Ensure that clinical trials are conducted in compliance with HIPAA and FDA regulations
• Secure and manage patient reports from the clinical trials
• Manage the Clinical Affairs and Research team in the absence of VP of Clinical Affairs

Certificate In Biomedical Regulatory Affairs, Regulatory Affairs

Relevant Coursework: Introduction to Biomedical Regulatory Affairs; Product Development & Manufacturing Systems; Product Testing.

Workshop-Introduction In Electronic Regulatory Submission (Ectd), Regulatory Affairs

Understand and follow the CTD structure; use the M4 series of guidances and granularity to generate compliant submissions.

Regulatory Affairs Cetificate: Pharmaceuticals & Devices, Regulatory Affairs

Relevant coursework: Medical Devices & Pharmaceuticals – US Regulations, Global Regulatory Strategy – Medical Devices & Pharmaceuticals.

Master Of Science (M.S.), Chemical Engineering

Relevant coursework: Biochemistry, Introduction to Biomaterials, Biochemical Engineering, Bioremediation of Hazardous Wastes, Engineering.

Bachelor’S Degree, Chemical Engineering