Therapeutic areas of focus: renal transplantation, oncology, microbiome biologic therapeutics, rare & orphan diseases, chronic kidney disease, ophthalmology, GI disordersClinical research experience: • drug development Phases 1, 2, & 3 • clinical laboratory operations • clinical trial management• operational execution & strategic planning of regulatory submissions • robust engagement with global Health AuthoritiesToolkit: End-to-end submission lead for project plans & timelines including content authoring; management of team review windows; comment adjudication coordination; securing subject matter expert content approvals; organizing formatting QC & coordinating document publishing activities; review & approval of eCTD dossier dispatch; & product label negotiations for: • Validation & RFI queries• Original IND & NDA filings• Orphan Drug Designation Requests; Fast Track & Breakthrough Therapy Applications• Initial & Substantial Modification CTA filings with TGA/Australia; ANVISA/Brazil; Health Canada; EMA/France, Germany, Spain; MHRA/United Kingdom• Lifecycle manager for DSUR 7-and 15-Day SUSAR reporting & Investigator Brochure annual updates (as appropriate)• Author & owner for BLA, IND, CTA, ODD & NDA submission timeline planning• Clear & purposeful communicator with US FDA CBER & CDER Divisions• Developer of regulatory strategy plans for clients' clinical development programs• Operationally excellent regulatory project manager with advanced experience in MicroSoft OneNote & Project; SharePoint; Box; Please review & SmartSheet™• Proficient user of GlobalSubmit™ web-based eCTD viewer & StartingPoint™ eCTD submission templates• Regulatory archivist proficient in Veeva Vault & TMF document management

Global Regulatory lead - US, EU, UK, AustraliaTherapeutic areas: rare & orphan diseases• Global Regulatory lead for early phase programs in rare & chronic diseases• Submission lead & strategist for Type C Meeting with US FDA• Submission lead for Orphan Drug Designation requests & a request for Scientific Advice• Partnered with external vendors to prepare & submit clinical trial application packages to health authorities in Australia, France, Germany, Poland, Portugal, Spain, & UK• Prepped responses to queries with cross-functional subject matter experts under tight timelines• Presented regulatory scenarios to executive leadership at internal strategic sessions

Regulatory lead - JapanTherapeutic area: Chronic kidney disease• End-to-end submission lead for J-NDA filing of VAFSEO®• Authored & managed submission timelines & submission content plans via Microsoft Project• Assessed & presented submission timeline risks with mitigation strategies to executive leadership

Regulatory lead - US Therapeutic area: ophthalmology• End-to-end submission lead for NDA filing of INVELTYS® (authoring/team review/comment adjudication/content approval/formatting QC & publishing oversight/eCTD dossier dispatch & validation/query responses/label negotiations)• Participated in face-to-face pre-NDA meeting with FDA• Managed external publishing vendor

Therapeutic areas: oncology, GI disorders, antimicrobials, genetically defined solid tumorsRegulatory Affairs Contractor• Submission manager for multiple clients in therapeutic areas of oncology, GI, antimicrobial, & solid tumor malignancies• Managed multiple CRO vendors to coordinate submission documents from authoring to review & content approval, formatting QC, & ensuring submission readiness• Implemented & maintained submission schedules; submission content plans; chronology logs; & regulatory strategy planning documents• Facilitated meetings with cross-functional subject matter experts to prep query responses to/from health authorities

Therapeutic area: oncology• Managed multiple external vendors for the development, tech transfer, & implementation of 200+ specialty assays for the execution of biomarker assessments across early phases of development for the Oncology Business Unit while mitigating risk

Therapeutic area: oncology biomarkers and clinical imaging• Laboratory manager for internal reference laboratories (molecular pathology, somatic mutation, immunoassay and biochemistry, & flow cytometry) located at Novartis sites in Cambridge, MA; East Hanover, NJ; & Basel, Switzerland

Therapeutic area: oncology biomarkers and clinical imaging• Executed strategies for biomarker assessments across early phases of clinical development for the Oncology Business Unit

Area of focus: Reproductive Pathology• Ensured smooth lab operation by coordinating supply orders, equipment maintenance & management of all protocols & standards• Prepared regulatory documents for initial & annual submissions to IRB & Ethics Committees