Consultant in Regulatory Affairs and Quality Assurance for the pharmaceutical, medical device and biologics industry. Background with orphan products, combination products, cell therapies and other unique products. Strong experience in development programs before and during investigational studies within the US or EU. Recent projects include:CE-Mark Application for Class 3 Medical Device with Ancillary Medicinal SubstanceQuality Management System creation and maintenance according to ISO 13485 and US GMPspreIND Meetingspre-pre-IND MeetingsGap Analysis for Quality SystemsRegulatory Strategy DevelopmentGuidance meetings and Scientific AdviceIND management, tracking, submission, maintenance Authorship of CMC sectionsReview of all IND sections for CTAs (including IMPDs)Electronic submissions with eCTD format

Company is focused on using targeted small molecule drugs to treat respiratory diseases (Cystic Fibrosis, asthma).Sr. Director, Regulatory Affairs- Lifecycle submissions for 2 INDs in eCTD format including preparation, publishing, QC and review (study reports, meetings, carcinogenicity SPAs, 1572 submissions, New Protocols, Protocol Amendments and IND safety reports)- IND Guidance meeting and package with FDA (Type C)- Scientific Advice meeting with EMA- EOP2 briefing packages for clinical, non-clinical and CMC meetings- Gap Analysis for Regulatory activities in preparation for Phase 3, NDA filing and commercialization- Regulatory Due Diligence activities for potential business deals - Employee Recognition Committee, Quarterly Disclosure Committee (10-Q)Chemistry, Manufacturing & Controls (CMC)- Identification and Qualification of CMC contractors for API, Drug Product and packaging/labeling activities- Oversight of CMC Operations team including strategy, goals and timelines- Process validation and launch strategy for API and Drug Product with CMC team- Gap Analysis for CMC activities in preparation for Phase 3 and commercial launch- CMC Due Diligence activities for potential business deals - Preparation of CMC sections for IND (updates, annual reports, scale-up)Quality Assurance- Updated and maintained quality systems for cavosonstat.- Gap Analysis for Quality activities in preparation for Phase 3 and commercial launch- Supplier qualification program including audits for sites and critical vendors- Oversight of Quality contractors including strategy, goals and timelines.- Prepared GCP audit plan for Phase 2 clinical studies with Clinical team