DEBRA HUHN, Notary Public
*** **** *****, ***** ****, NJ 08502
973-***-**** email@example.com, Linkedin.com
Associate Regulatory Specialist
Regulatory Professional in Personal Care, Healthcare, Pharmaceutical, and Consumer Product industries. Progressive skill in Regulatory Affairs product registration at the global level. Specialist in change of site location, ancillary documents.
KEY AREAS OF EXPERTISE
Project Management Technical Databases Life Cycle Management
Time Management Calendar Management Chemistry Manufacturing Control
Budget and Financial Tracking Lorenz eValidatorDay-to-Day Document Control
Key Performance Indicator (KPI) Mutual Recognition Procedure FDA Web Portal Submissions
COMPUTER SKILLS /PROFESSIONAL EDUCATION
Visio Technical Data System Roxio
MS (Word, Excel, PowerPoint) Publisher Design-Pro
MS Outlook/Calendar MAC Computer Adobe Acrobat
SharePoint 2010 Agile CREDI
CompuMaster – Morristown, NJ
Getting the Most from Microsoft Excel
How to Build Powerful PowerPoint Presentations
Rockhurst University Continuing Education Center – Cedar Knolls, NJ
Conference for Women
CDM Technical Training Institute – Wayne, NJ
Microsoft Excel 60 Hours
Notary Public (Sussex & Morris County)
FDA eCTD Overview and Submission
BioPharma Institute – GMPO: Documentation and Record Keeping (an Abridged Course)
PRA03: Preparing Submissions: Common Technical Document Form
Medesun Healthcare – Medical Coding & Billing
Integris3 BioSolutions, NJ 5/23/2018-Current
Project Management / Administrator
oFDA Electronic Submissions through Gateway- uploaded submissions, Annual Reports and PADERs
oDay-to-day Timeline Management
oDrafting of documents, presentation content, monthly reports, documentation of process improvements
oAssisted clients with documentation such as leaflets and labels
oReviewed Module 1, Module 3, and Module 5 before submitting to the FDA.
Novartis, East Hanover, NJ 2016-2/9/2018
Quality Control Submission Coordinator – Contract Position
oProvide operational support to the Oncology QC Submission Manager
oSupport vendor oversight and quality activities including: KPI monitoring, metrics collection and reporting as well as adherence to Oncology Submission Management and NVS guidelines.
oResponsible for qc findings form for Module 2
oDocument Control – prepare, review, approve, change, and delete documents for Module 2
Colgate-Palmolive, Piscataway, NJ 2016-8/3/2016
Regulatory Affairs Specialist – Contract Position
oSupport International Product Registrations for Most of the World
oProvide technical Regulatory and process support for Regulatory submission documents.
oEnsure Regulatory documents are maintained according to internal procedures.
oIn conjunction with new registrations, gather and prepare product registration documents.
Edgewell Personal Care – formally Energizer Personal Care, Allendale, NJ 2015-12/11/2015
Sr. Regulatory Affairs Associate
Support International Product Registrations for LATAM and Asia Pacific Markets
oCompile documents to support submissions to Edgewell affiliates or government authorities.
oGood Manufacturing Practices
oExecute FDA-Certificates to Foreign Government
oCertificate of Free Sale
oUS Legalization – Apostille or Consulate
oLATAM Dossier Assembly – Sun Care & Skin Care
oMaintain up-to-date product registrations including registration expirations, discontinuances or product changes.
oTrack, identify and measure trends in Regulatory transactions and initiatives.
Merck Sharp & Dohme Corp., Pharmaceutical, Kenilworth, NJ 2012-10/31/2014
Regulatory Scientist Assistant II – Contract Position
(Assistant to Regulatory Scientist)
oPivotal role for requesting most of world registration documents required to support Chemistry Manufacturing Control (CMC)
oSupport CMC variations such as drug product manufacturing site change
oRequests all ancillary documents:
oCPP – Certificate of Pharmaceutical Products – registrations of medical devices
oGMP – Good Manufacturing Practice
oPoA – Power of Attorney
oLoA – Letter of Authorization
oML – Manufacturing License
oLegalization of ancillary documents:
oNotarize – created and notarized authenticity letters
oApostille – documents sent to the country's embassy or consulant for legalization
oAssist with Health Authority questions.
oCreated and Maintain Track Requests
oLiaise with manufacturing sites, local regulatory liaisons to identify and obtain ancillary documents.
oAssist with Global Submission EU projects
Summary of Job Duties: Assist with regulatory documents for Module 3, sections 3.2S and 3.2P necessary for submission to the Health Authority.
Request Certificate of Pharmaceutical Products from the FDA and all over the world.
Compiling ANDAs, supplements, and annual reports.
Reckitt Benckiser, Global Consumer Goods, Parsippany, NJ 2009-2011
Global Regulatory Safety Environmental Assistant
oPerformed critical administration to enable smooth team function. Scheduled and coordinated Metrics and KPI’s, calendar management, created master team calendars.
Developed a central electronic repository system and maintained files.
oAssisted in the preparation of regulatory submissions dossiers.
Developed and implemented budget tracker to accurately track expenses.
Coordinated meetings and events for up to 50 local and remote attendees, organized all logistics, selected an internal or external site, confirmed facility arrangements, managed food distribution, facilitated participant coordination, prepared materials and updated PowerPoint presentations.
Notarized and processed Certificate of Pharmaceutical Products and Certificate of Free Sales.
Developed and maintained Local Regulatory Contact List, country, contacts co-authors, manager, and regional head.
Pre-screened studies and protocols in the Quality Assurance Unit
Coty Inc, Research & Development Center, Fragrance & Toiletries, Morris Plains, NJ
Registration Coordinator, Regulatory Affairs 2009
Responsible for registering the entire line of Coty domestic products overseas.
Liaison between R&D, Personal Care Products Council, and global Marketing as regards to all registration activities.
Created, generated, and maintained Affidavits, Certificate of Free Sales, BSE Certificates, Certificate of Analysis, Test Procedures, Artwork, Stability Certificates, GMP’s, Raw Material Specifications, Formulas w/functions, Packaging Specifications, Manufacturing Specifications, Product Specifications, and Standard Operating Procedures. Most of these documents were generated through Enginuity.
Established tracking system via Excel to consolidate and improve existing reporting process.
Created and maintained PIP’s (dossiers)
oTrained registration team for backup support.