Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing

ID: 733372 New York, USA

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Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has experience with Management and buildout of multiple interdisciplinary departments: Device Development, Device Manufacturing, Investigations, Regulatory Affairs, and Human Factors. He also has Developed state of the art products and supported approval of combination products (Eylea, Praluent, Dupilumab, Fasinumab and Sarilumab), patch pumps, auto-injectors, syringes, defibrillators, oxygen monitors and regulators, and dental products.

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.

Regulatory/Compliance

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


Manufacturing/Industrialization

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

Education

Year Degree Subject Institution
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

Work History

Years Employer Title Department
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 Employer Title Department
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 Employer Title Department
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 Employer Title Department
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 Employer Title Department
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 Employer Title Department
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 Employer Title Department
Years: 2000 to 2004 Employer: Lingvobit Title: Marketing Specialist Department: Marketing and Sales
Responsibilities:
Marketing and Sales of electronic products.
Years Employer Title Department
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.

Government Experience

Years Agency Role Description
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

Career Accomplishments

Associations / Societies
RAPS
PMI
PDA
Licenses / Certifications
RAPS - US and Global
PMP
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

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