• Regulatory lead for the IND driving FDA approval of Pretomanid™ drug via Orphan Drug and Fast Track Designation programs

 

• Served as point-of-contact during FDA inspection of more than 35 biopharmaceutical and vaccine manufacturing operations across the US, demonstrating unprecedented growth over a three-year period with respect to new facility registration and licensure 

 

• Served as Technical Lead for more than 20 NIH funded translational science  projects over a five-year period

 

• Achieved $1M+ YOY savings at multiple organizations by increasing operational efficiency through introducing new electronic document management systems, streamlining operations via workflow auditing, and improving workflow through strategic team management

 

• Defined regulatory strategies for compliance with regulatory authorities such as FDA, EPA, OECD, ICH, EMA, OSHA, USDA, HIPAA, and other research and regulated product development regulations

 

• Facilitated identification, contracting, and training for clinical sites, institutional review board (IRB) approval, and initiation of clinical trials for U.S. and international firms. 

 

• Successfully managed 500+ regulatory assessments and audits for FDA- licensed operations and medical device products.

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• Served as FDA Authorized Official/Regulatory Point of Contact for companies in the biotech, biologics, in vitro diagnostics, and medical device industries. 

 

• Designed and reviewed 100+ validation plans/protocols for computer systems, medical devices, and operational procedures in GMP-, GLP-, and GCP-regulated environments.

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• Designed, developed, and implemented 1,000+ regulated documents consisting of SOPs, training plans, validation plans, and licensing submissions.