Resume

Sign in

Manager Assistant

Location:
Princeton, New Jersey, United States
Posted:
September 28, 2018

Contact this candidate

Resume:

DEBRA HUHN, Notary Public

*** **** *****, ***** ****, NJ 08502

973-***-**** ac67us@r.postjobfree.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

CERTIFICATION

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

PROFFESSIONAL EXPERIENCE

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.



Contact this candidate