Regulatory Affairs Change Management
Resume:
Carma Delores HoDge
PHarmaCeutiCal regulatory affairs Professional
*****.*****@*****.***
Maryland Heights, MO, USA
LinkedIn.com/in/carmahodge
PROFESSIONAL SUMMARY
Seasoned regulatory professional with expertise in global submissions, change management systems, and implementing global regulatory strategy plans, committed to ensuring regulatory compliance to meet global health authority guidelines and regulations. More than 15 years of experience in pharmaceutical and biotechnology industries comprised of: formulation development of early and late stage biotherapeutic products for human use, clinical sciences and in-vitro diagnostic (IVD) medical devices, and regulatory CMC for global investigational and commercial drug products. Dedicated to fostering stakeholder relationships, and advancing organizational goals in the areas of: Regulatory, Medical, or Clinical Affairs, Technical Writing, Project Management, Quality and Compliance, or Clinical Sciences. EXPERTISE
Product experience in small molecules, biologics, ophthalmic combination products, and IVD medical devices
Submission authoring and reviewing in e-CTD format, adept at using submission-ready software and templates INDs, NDAs, ANDAs, BLAs, supplements PAS and CBEs, EMA Type II and Ib variations, NOC commitments
Implementing regulatory strategy developed to support markets/regions: US, EU, CAN, LATAM, APAC, AUS, EMEA Self-driven to gather regulatory intelligence for global requirements to navigate the regulatory landscape
Change control/change management processes, and Quality Management Systems (QMS) to assess: Drug substance and drug product changes, Market impact assessments, Global regulatory filing requirements
Submission management processes, and Electronic Document Management Systems (EDMS) to include: v-Doc builds, submission planning templates for modules 1, 2, and 3, document quality control and approval Document life cycle management: creation, editing, reviewing, approving
Technical writing and editing: SOPs, Dosage and Administration Instructions (DAI), technical reports, batch records
Managing regulatory affairs CMC projects
CORE COMPETENCIES
Knowledgeable of Health Authority Guidelines: FDA, EMA, HC, ICH
GMP/GLP compliance, Knowledgeable of GCP, environments compliant with: 21 CFR 820, ISO 13485, MDSAP
Working across functional lines: Regulatory Ops, Local Country Offices, Quality, Clinical, Manufacturing, other functional areas
Capable of working independently and in a matrix team environment Software Applications
Proficiency: Documentum, Liquent Insight, Lorenz DocuBridge, TrackWise, Product Dossier Management (PDM), Clinical Aggregate Layer (CAL), MS Predict, MS Office Suite, SharePoint, Teams, Adobe Acrobat Pro
Working Knowledge: SAP, Kintana, CatsWeb, Veeva Vault, Metric Stream, Box, Ring Central, Zoom PROFESSIONAL EXPERIENCE
Regulatory Affairs CMC Regulatory Quality & Compliance-IVD Devices Regulatory CMC Manager – Black Diamond Networks, Andover, MA Oct 2021 – Oct 2023
(Clients: Bausch & Lomb, Medicago, Tiziana Life Sciences)
• Authored supplements and variations to support post-market changes to ophthalmic solutions, ointments, and combination products marketed in the US, EU, and rest of world (ROW). Submission changes included multiple-product, bundled, and individual.
• Authored CTD Module 2 QOS for multiple drug products using Drug Master Files (DMF), and USP Monographs.
• Authored US annual reports and associated dossier sections to reflect post-market updates through reporting period.
• Drafted/completed Module 1 documents: cover letters, FDA application Form 356h and annual report Form 2252.
• Created submission events, and submission planning records to capture relevant Module 1, 2, and 3 dossier content per submission. Created v-docs for submission builds in Documentum, used DocuBridge to access e-CTD structure and content for global dossiers.
• Biosimilar BLA remediation project to provide stakeholder recommendations to ensure alignment with FDA and ICH guidelines.
• Dossier alignment project to manage Module 2 and 3 document versioning for US and ROW markets.
• Examined drug substance and drug product change requests for impact to global dossiers, and ran queries for annual reportable changes using the Kintana change management system. Authored new CMC content where appropriate, and updated existing content to reflect post-approval changes, based on technical and validation reports, stability data, DMFs, and USP Monographs.
• Worked across functional lines with SMEs, Manufacturing, Submission Ops, and other functional areas to enable CMC submissions.
• Authored CMC submissions for Health Canada (HC) to support health authority-driven commitments for the Notice of Compliance
(NOC) for a novel plant-based Covid-19 vaccine. Authored responses using technical reports, investigation reports, and CAPAs.
• Prepared or drafted Module 1 documents for electronic applications, cover letters, submission life cycle management logs, and applicable Module 3 documents to support applicant responses to health authority commitments. Carma Delores HoDge
PHarmaCeutiCal regulatory affairs Professional
*****.*****@*****.***
Maryland Heights, MO, USA
LinkedIn.com/in/carmahodge
• Worked across functional lines with Global Publishing, to facilitate creating submission events in DocuBridge, dispatching submission content, and performing quality control checks of published output for electronic submission through the HC portal.
• Managed project for NOC commitments regarding Clinical, Pharmacovigilance (PV), Labeling, and CMC. Managed commitment timelines, tracked entries, communicated data requirements to stakeholders, provided status updates to leadership, and team meetings.
• Assessed change control requests using the quality management system, for changes impacting drug substance, drug product, and manufacturing processes for a vaccine. Determined appropriate filing action and regulatory requirements according to HC guidelines.
• Co-drafted an SOP to address post-market changes impacting CMC, PV, and Labeling to meet HC and FDA reporting requirements.
• Gathered regulatory intelligence for HC reporting requirements for annual summary reports, and annual drug notification forms.
• Authored IND, M3 drug substance sections for a human parenteral biologic for 3.2.S.2 Description of Manufacturing Process & Process Controls, Control of Critical Steps & Intermediates, and Manufacturing Process Development, and 3.2.S.6 Container Closure System.
• Constructed upstream and downstream process flowcharts, and identified critical process steps and in-process control through extensive review of drug substance batch records to facilitate authoring applicable drug substance sections.
• Researched vendor product specification sheets, and technical drawings applicable to drug substance storage containers to support authoring the container closure narrative.
Senior Manager, CMC Regulatory – PRA Health Sciences, Raleigh, N.C. (supported Takeda USA) Jan 2020 – Aug 2021
• CMC Product Lead for a small molecule commercial diabetes product marketed worldwide.
• Managed change management processes, authored global submissions for post-approval supplements and variations, coordinated with Local Country Offices to confirm market regulatory strategies.
• Supported product divestment and withdrawal activities, and maintained market specific product checklists.
• Determined regulatory submission requirements and filing documentation required to meet ICH and global health authority guidelines.
• Managed change management processes, using the TrackWise quality management system. Assessed regulatory impact and authorized change control requests impacting APIs, drug product, manufacturing equipment, and contract labs change for post-marketed products.
• Authored CTD sections for dossiers to include Module 2 QOS and Module 3 Drug Substance, Drug Product, and Regional Information, to support filing MAAs, ANDAs, and MA variations, according to requirements established by regional or country guidelines.
• Created submission planning records for relevant Module 1, 2, & 3 content and documentation applicable to global submissions.
• Used Documentum to create submission content, manage life cycle events, and approve submission-ready documents.
• Managed a compliance gap analysis project for a commercial product to address gaps identified in market specific dossiers versus manufacturing site documentation. Performed regulatory assessments to determine appropriate regulatory action for identified gaps, conducted investigation of the Liquent dossier repository to establish which gap(s) had been closed through previous submissions. Provided recommendations to Quality Lead and other stakeholders regarding appropriate resolutions for substantiated gaps. Performed regulatory assessment for associated change requests per impacted markets where required.
• Worked across functional lines with Submissions Management, Global Publishing, and Local Country Offices to facilitate creation of submission events, and to support the dispatch of submission content for filing with global Health Authorities per country. Regulatory Specialist – Volt Technical Services (at bioMerieux Inc, Hazelwood, MO) Jan– May 2019
• Assessed customer complaints regarding IVD medical devices, determined cause of harm, or potential harm to patient or end user safety.
• Maintained the life cycle of each adverse event report (AER) regarding complaints for adverse events and/or device malfunctions using TrackWise. Located relevant product information required to assess and investigate presumed material lots.
• Prepared and submitted FDA Form 3500 Medical Device Reports (MDRs) as per 21 CFR Part 803, to report device-related adverse events, product problems or malfunctions determined to have caused, or potentially caused harm/injury to patients or end users.
• Prepared and submitted Supplemental MDRs to the FDA to address reporting events and malfunctions, requiring company CAPAs, investigations to diagnose the root cause(s) of complaint issues.
• Worked across functional lines with Customer Service to ensure capture of pertinent information from customers, to facilitate full assessment of complaints to determine FDA reportability. Global CMC Author/Strategist – NCS Technologies Inc (at Pfizer Inc, Weldon Spring, MO) Jun 2015 – Dec 2018
• Regulatory CMC Change Management Lead for an investigational biologic drug product. Initiated, authorized, and approved drug product change management processes for commercial and investigational products. Assessed regulatory market impact, and determined appropriate filing action for regions: US, EU, APAC, LATAM, CAN, MEA.
• Investigated and resolved complex Product Change Form (PCF) issues for multiple investigational and commercial products to bring PCFs and File Later Log issues to a completed state. Troubleshot PCFs and PDM Outline issues, to facilitate document status updates. Identified market/regional filing strategies using the Gnosis application to enable resolution of open PCFs.
• Monitored the status of ongoing clinical trials in various phases, to track trial completion per market/region using the CAL application. Carma Delores HoDge
PHarmaCeutiCal regulatory affairs Professional
*****.*****@*****.***
Maryland Heights, MO, USA
LinkedIn.com/in/carmahodge
• Created submission planning records for amendments to INDs and IMPDs, and submission build templates (SBTs) for BLAs, INDs, and IMPDs. Initiated submission plan records for regulatory commitments, updated data to edit, complete, or close commitments.
• Assisted with authoring Module 2 and 3 IMPD sections according to requirements and formats for regional or country guidelines.
• Served as a member of a project team for post-market resolutions to facilitate dossier management and enable a streamline dossier.
• Managed project performing a gap analysis for a commercial product to identify gaps in the registration license system and/or the change management system to determine conflicting or missing information in each system. Located current product license, registration, and package set information for commercial products, in order to determine alignment with the commercial change management system to maintain compliance. Facilitated data resolutions through outreach to country offices and/or regional strategists to mitigate potential compliance risks.
• Managed project to transfer technical documents for a biologic product from a noncompliance SharePoint site into Documentum for compliance and life cycle management. Managed translation needs and uploading, batch records, technical reports, data records, and other manufacturing documents. Created a master spreadsheet to record SharePoint folder hierarchy, manage document metadata, and map Documentum location, to support data verification and review of regulatory submissions. Communicated project status updates to leadership and stakeholders.
• Collaborated and worked across functional lines with QA, ARD, Supply Chain, and other colleagues to facilitate Release On Approval
(ROA) of drug product. Served as the Global CMC rep for QA-ROA team meetings, provided necessary GCMC documents or data to support the ROA process. Reviewed Drug Supply Forms, and/or other required documents for clinical supply release.
• Facilitated Supply Chain and Medical Affairs colleagues by using Documentum to locate required CMC and QA documents to support various global operations.
Regulatory Affairs Specialist – Aerotek Scientific (at Mallinckrodt Inc, Hazelwood, MO) Oct 2014 – May 2015
• Prepared submission documents and applications for worldwide registration of radiopharmaceutical drug products with health authorities in the regions of Asia Pacific, Middle East Asia, Latin America, Europe, and Canada.
• Secured US FDA Certificate of Pharmaceutical Products to facilitate approval of Applications and Renewals for drug products marketed in accordance with international export/import regulations. Worked with Washington Consular Services to obtain document Apostille or Embassy Legalization as required by global health authorities.
• Collaborated with RA managers and colleagues to achieve goals for changes in Marketing Authorization Holders, variations, and product renewals. Completed applications materials, compiled stability data, submitted Embassy Legalized/Apostilled documents.
• Compiled Module 3 CMC drug substance and drug product sections, and Module 2 Clinical and Non-Clinical summaries. Assisted in the compiling Product Quality Review Reports for marketed drug products.
• Reviewed product labels and package inserts to address concerns related to regulatory filings. Actively participated in team decisions that impacted labeling requirements for international submissions and manufacturing implementation.
• Served on project teams to resolve technical product, packaging, and labeling issues related to international regulatory filings.
• Worked across functional lines with Legal, and Quality Assurance to facilitate divesture activities. Technical Writer – Townsend and Associates (at Meridian Medical Technologies, Maryland Heights, MO) Aug – Sep 2014
• Redesigned pharmaceutical documents such as SOPs, master batch records, and Bill of Materials to meet FDA compliance requirements.
• Created document change histories, redlined versions, completed review processes, tracked changes through Document Control, and routed for signature approvals.
Clinical Trial/Clinical Sciences, In-Vitro Diagnostics Clinical Research Associate/Clinical Scientist – Volt Technical Services (at bioMerieux Inc, Hazelwood, MO) Dec 2012 – Jun 2014
• Performed clinical studies to support new and expanded FDA label claims for Vitek 2 and Vitek 2 Compact Antimicrobial Susceptibility Testing (AST) Etest IVD medical devices. Processed and upload clinical data to the EDC (electronic data capture) system.
• Facilitated start of clinical trials by reviewing/editing clinical plans and protocols, preparing clinical trial site documents, organizing clinical binders, ordering/shipping trial supplies, and culturing and shipping isolates for clinical sites. Facilitated close of clinical trials by reviewing/editing interim and final reports, analyzing/reviewing data to determine essential and category agreements.
• Performed validation support studies to ensure the Medidata Rave (EDC) application design was suitable for clinical trial site use. Executed protocols to determine if each step would yield the desired data entry for CRFs, collected results for clinical trial sites and the internal Clinical Trial Manager.
• Facilitated Phase II verification studies for AST Etest IVD device products to support clinical trials using fastidious species. Performed species testing with Etest products for bacterial cidal and bacterial static drugs, and broth microdilution reference testing. Compiled, collated, reviewed data to help determine which organisms were acceptable for use in the clinical trial.
• Facilitated the investigation studies for Chrom ID agar to determine the most effective procedure for the clinical trial protocol. Carma Delores HoDge
PHarmaCeutiCal regulatory affairs Professional
*****.*****@*****.***
Maryland Heights, MO, USA
LinkedIn.com/in/carmahodge
Parenteral Formulation Development, Biologics
Senior Associate Scientist, Associate Scientist – Pfizer Inc, St. Louis, MO Oct 2004 – Oct 2011
• Development of biologic parenteral formulations for liquid and lyophilized biotherapeutic proteins of monoclonal antibodies, protein- lipid complexes, and other protein molecules for the therapeutic areas: oncology, pain, inflammation, cv-med and others.
• Enabled formulation development of Phase III oncology product, ahead of projected timeline by, designing, writing, and executing DAI verification protocols to determine compatibility with disposable dosing components, to support the commercial label for marketing.
• Enabled formulation development of a matching placebo to a protein-lipid formulation to facilitate double-blind Phase IIB clinical trials.
• Led and executed a variety of technical studies by managing time points and delegating personnel to perform designated assays.
• Designed, drafted, and executed a variety of Rational Design of Experiment (DOE) stability protocols and formulation batch records to determine drug substance and drug product stability profiles and quality attributes of therapeutic protein formulations.
• Analyzed data and wrote comprehensive study reports pivotal to regulatory submissions and IND filings. Prepared and presented scientific presentations for technical teams, department, and extended team meetings.
• Served as subject matter expert for: DAI verification protocol designs, reviewing DAIs for clinical submissions, DAI and DAI SOP related training, providing technical expertise to support various clinical site questions.
• Ensured awareness and appropriate use of DAIs with clinical and commercial drug products and dosing components. Trained and mentored Clinical Study Managers/Monitors (CSMs), Investigators, internal/external clinicians, global pharmacists, Supply Chain, and Biotherapeutics colleagues.
• Advised pharmaceutical and analytical colleagues regarding appropriate experimental designs and testing methods for DAI verification studies, through small group interactions and scientific presentations at department meetings.
• Facilitated the start of ~50 new global clinical site protocols, by evaluating dosing materials and making informed decisions regarding compatibility with designated drug products.
• Expedited the start of, or continuation of, patient dosing for numerous Phase I-III clinical protocols by providing timely feedback to clinical site questions, through communications with roughly 15 CSMs spanning 100+ global clinical sites.
• Implemented changes to DAI format to facilitate investigator processes in dosing of investigational study drugs by incorporating feedback collated from clinical site visit, and Pharmacy Operations colleagues.
• Participated in project meetings, as the scientific liaison, with Lead Formulation Scientists and Clinical Operations colleagues to determine how the clinical study protocol designs impact implementation of DAI verification study protocol designs.
• Established positive rapport with nationwide and global vendors to obtain pertinent component information used in determining compatibility with biologic drug products.
SELECTED TECHNICAL SKILLS
Formulation Development
• Excipient Selection, Excipient and Buffer Robustness, Lyophilization Optimization
• Freeze-Thaw Stability, Process Material Compatibility, Bioprocess Component Compatibility
• Visual Appearance Testing & HIAC, Dynamic Light Scattering (DLS), Zeta Potential Analysis
• Differential Scanning Calorimetry (DSC), Powder X-Ray Diffraction (PXRD), Freeze-Dry Microscopy (FDM) Biotechnology
• SDS-Page, iCE, PCR: DNA/RNA, DNA Sequencing, Western and Northern blots
• Broth Microdilution, Microbial Culture, Antimicrobial Susceptibility Testing (AST): Etest, Vitek 2/Vitek 2 Compact, Chrom ID Agar Manufacturing
• Clean Room: Classes 100/1,000/10,000, Aseptic Technique, Cell Counting, Cell Culture: 100 & 500L Bioreactors
• Centrifugal Cell Separation, Protein Purification via Skid, Conductivity, Osmometry, Densitometry EDUCATION
• Regulatory Affairs Certificate: (Dual) Medical Devices And Pharmaceuticals, RAPS Online University Expected Oct 2024
• Project Management Professional Certificate, Project Management Institute Expected Oct 2024
• Lean Six Sigma Yellow Belt, American Society for Quality 2008
• Graduate Program, Biomedical Sciences, 33.0 hours towards Ph.D., Meharry Medical College, Nashville, TN 1994-1997
• B.A. Chemistry, Basic Specialization, Southern Illinois University Edwardsville, Edwardsville, IL 1994 PROFESSIONAL AFFILIATIONS
Regulatory Affairs Professionals Society (RAPS) Project Management Institute (PMI) American Society for Quality (ASQ) Carma Delores HoDge
PHarmaCeutiCal regulatory affairs Professional
*****.*****@*****.***
Maryland Heights, MO, USA
LinkedIn.com/in/carmahodge
PREVIOUS PROFESSIONAL EXPERIENCE
R&D Formulation Development Product Development Biopharmaceutical Manufacturing Production Research Assistant – Aerotek Scientific (at AFB International), St. Charles, MO
• Worked cross-functionally with Regulatory Affairs to secure USDA Export Certificates, Product Labels, Brochures, and CoAs.
• Completed international shipping of pet food products, in accordance with international export/import Customs regulations.
• Facilitated the investigation and resolution process for a failing commercial product, by contributing to Product Champion studies to determine the cause and effect of the product specification issues. Reviewed, collated, and compiled data from multiple batch records to facilitate manufacturing remediation efforts of process/process-related issues for commercial products.
• Designed/executed Rational Design of Experiment (DOE) studies for formulation development of pet food palatants, and health & wellness products. Analyzed DOE data to enable the design of subsequent DOE formulation development studies.
• Drafted formulation batch records, and executed pilot plant manufacturing runs to meet customer product specifications and quality expectations. Performed chemical hydrolysis, and maillard reactions, % Moisture and Solids, ASH, and pH.
• Employed pilot plant manufacturing skills of dry blending, sieving, and spray drying of formulated pet products and ingredients.
• Used cGMP, and appropriate gowning techniques for the plant environment. Process Technician II – Genetics Institute (Wyeth Pharmaceuticals), St. Louis, MO
• Manufactured biopharmaceuticals used to treat the blood disorder hemophilia, through collaborative team work.
• Process optimization experiments for bioreactors and purification steps, supported tech transfer and process validation studies.
• Developed mammalian cell culture expertise from T-flask to 100 & 500L bioreactor inoculations and culture maintenance.
• Acquired technical skills centrifugal cell separation, and protein purification using Pharmacia skid and Unicorn 3.0 software.
• Drafted manufacturing equipment SOPs. Ensured proper colleague training on SOPs, lab equipment, and production procedures.
• Demonstrated proficiency in cGMP by maintaining a 99% error-free GMP documentation record.
• Maintained production database using MS Access with relevant data extracted from production batch records.
• Clean Room Gowning: Classes 100/1,000/10,000, aseptic technique, cold room, and buffer prep experience. Laboratory Technician, Formulation Chemist, Formulation Assistant – Lab Support, St. Louis, MO
(Clients: Steris Corp, Vi·Jon Labs, Universal Flavors)
• Performed GLP method development assays in a P3 lab, handled gram negative and positive microorganisms: sporoforms, bacteria, yeast to include Salmonella, E. coli, Methicillin Resistant S. aureus (MRSA), Vancomycin Resistant Enterococci (VRE).
• Facilitated development of a pre-operative prep scrub product using pigskin methodology testing.
• Contributed to research efforts aimed at cloning the gene responsible for mutant behavior in triclosan resistant bacterial strains.
• Performed minimum inhibitory concentration and time kill assays, preservative efficacy testing, pigskin testing, cell culture.
• Formulation Chemist of health and beauty aids, predominantly responsible for product development, and preparation of master formulations for three products, which were each new to the retail market.
• Contributed notably to the product development of several existing products, and some newly marketed product lines.
• Supervised several GMP production runs performed by a CMO for multiple products, troubleshot complex production issues.
• Prepared original formulations using polymer and surfactant blends, selected suitable fragrances and dyes.
• Determined product specifications, drafted associated product spec sheets and component analytical reports.
• Performed extensive product, and product packaging stability assays, and product specification assays.
• Product development, formulation development of food ingredients used in food applications.
• Met customers’ demands through assays tailored to achieve desired product specifications.
• Determined product specifications, drafted associated product spec sheets and component analytical reports.
• Used induction plates, large capacity steam-jacketed and swept surface kettles, to prepare different kinds of food ingredients.
• Evaluated products for desired color, flavor, and texture as part of product development, conducted pilot plant runs for food products.
• Performed product specification assays such as soluble solids, pH, water activity, and bake test. Laboratory Assistant – American Red Cross, Nashville, TN
• Production team responsible for processing blood, which supplied all hospitals and labs, within the Tennessee Valley Region.
• Processed human blood into platelets, plasma, and red blood cells used as injectable pharmaceuticals, in a GMP environment.
• cGMP, Data entry, daily quality control of laboratory equipment. Laboratory Technician – Sigma Chemical Company, St. Louis, MO
• Isolated, purified monoclonal/polyclonal antibodies from animal sources, into bulk product in a GMP production environment.
• IEP, SDS-Page, IE-chromatography, UV spectroscopy (A280/A260), protein titer, Bradford Assays, adsorption techniques.
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