Expert in Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert ID: 733372 New York, USA
Expert is an industry leader and was a speaker at:
4th Annual Pre-Filled Syringes Summit
BPD Advances in Drug Delivery & Devices Symposium
Human Factors Engineering & Usability Studies Summit
He also chaired ACI's European Pre-filled Syringes Summit
Expert has an engineering background with MBA education, and PMP, RAC (US and Global), Six Sigma Certifications. Currently Sr. Manager, Combination Products, Regulatory Affa at Regeneron Pharmaceuticals, Inc.
Hands on Regulatory experience with FDA, EMA, Health Canada and PMDA.
RAC certified (US and Global)
Led FDA and EMA negotiations, correspondences, proposed and negotiated regulatory strategy, supported BLA and 510K filings.
21 CFR 820.30 Design Controls
Primary Container selection for Drugs and Biologic, vendor and CMO selection and management. Fill finish. External Manufacturing.
Industrialization for medical devices and combination products.
cGMP Requirements and compliance
CMC leader for late stage and early stage programs. Lead RA activities for multiple early and late stage programs. Worked on both biologics and small molecules. Extensive expertise in drug development, submission, manufacturing, CMO and CRO management and other pharmaceutical topics.
Medical Device and Combination Product Regulatory Questions and Submission strategy
Medical Device and Pharmaceutical Labeling
Regulatory Requirements for Drug ProductsCombination Products Primary containers industry
Manufacturing of Drug Industry containers
Glass Breakage InvestigationStartup investing and Production Strategy
Strategic development of new markets for drugs and medical devicesOutsourcing Global Strategy
Expending Manufacturing Capabilities
|Year: 2009||Degree: Bachelors of Science||Subject: BioEngineering||Institution: University of Illinois at Chicago|
|Year: 2010||Degree: Masters of Business Administration (MBA)||Subject: International Business and Management||Institution: University of Illinois at Chicago|
|Year: 2016||Degree: Regulatory Affairs Certification||Subject: US Regulations||Institution: RAPS|
|Year: 2016||Degree: Regulatory Affairs Certification||Subject: Global Regulations||Institution: RAPS|
|Year: 2012||Degree: Project Management Certification||Subject: PMP||Institution: PMI|
|Year: 2010||Degree: Six Sigma Manufacturing Certifiaction||Subject: Black Belt||Institution: ADMD|
|Years: 2015 to Present||Employer: Undisclosed||Title: Sr. Manager Combination Product Regulatory Affairs||Department: Clinical Development Regulatory Affairs|
Responsibilities:Led Combination Products Regulatory Affairs group and all activities. Negotiating with FDA, EMA, and correspondence with global health authorities. Provided regulatory strategy and supported submission and approval of current and new products.
|Years: 2012 to 2015||Employer: Regeneron Pharmaceuticals, Inc.||Title: Manager Device Development||Department: Technical Operations|
Responsibilities:Led Device Development, Manufacturing, Human Factors and Investigations groups and all activities.
|Years: 2011 to 2012||Employer: Ohio Medical Corporation||Title: Engineering Manager/Project Engineer||Department: Engineering|
Responsibilities:Led oxygen regulator, oxygen monitor and negative therapy pressure pump development and industrialization.
|Years: 2011 to 2011||Employer: Inter-Med / Vista Dental Products||Title: Product Development Project Manager||Department: Innovation and Advanced Technology Department|
Responsibilities:Developed advanced dental products, new technology and worked directly with CMOs and company owned manufacturing in the U.S. and China.
|Years: 2008 to 2010||Employer: Zoll Medical Corporation||Title: Design Engineer||Department: Research and Development Department|
Responsibilities:Developed state of the art critical care monitoring unit and defibrillator, Propaq MD and M, to successful regulatory approval and product launch.
|Years: 2004 to 2008||Employer: University of Illinois at Chicago||Title: Multiple Positions - Design Engineer, Research Assistant, Radiation Safety Tech||Department: BioEngineering Department / Department of Orthopedics|
Responsibilities:Developed cartilage test equipment, conducted Radiation Safety work and nuclear medicine/laboratory inspections.
|Years: 2000 to 2004||Employer: Lingvobit||Title: Marketing Specialist||Department: Marketing and Sales|
Responsibilities:Marketing and Sales of electronic products.
|Years: 2017 to Present||Employer: Undisclosed||Title: Director, CMC & Combination Products Regulatory Affairs||Department: CMC Regulatory Affairs|
Responsibilities:Expert leads multiple program CMC RA activities and combination product planning. Work on novel iRNA treatments, R&D strategy, CRO & CMO selection and leadership, Regulatory strategy, and other pharmaceutical activities.
|Years: 2004 to 2008||Agency: University of Illinois/ UIC Hospital||Role: Radiation Safety Technician||Description: Worked with Nuclear medicine and university laboratories on Radiation safety regulations, testing and compliance|
|Associations / Societies|
|Licenses / Certifications|
|RAPS - US and Global
Six Sigma Black Belt
ISO 13485 Lead Auditor
|Publications and Patents Summary|
|Multiple patent applications filed for combination and medical devices, and related products.|
Fields of Expertise
syringe, electronic medical device design, biomedical device design review, biomedical device engineering, human factors engineering, human factors, medical device design, biomedical device, Code of Federal Regulations, medical device patent, 510(k) document, medical device premarket approval, Food and Drug Administration validation, FDA medical device regulation, Food and Drug Administration, biomedical device manufacturing, Good Manufacturing Practice training, Current Good Manufacturing Practice auditing, Good Manufacturing Practice, medical device manufacturing, medical device manufacturing automation, medical device manufacturing troubleshooting, medical device manufacture clean room, biopharmaceutical, strategic marketing, radiation safety code, radiation safety