Profile Regulatory support professional offering strong project

management skills. Able to work under pressure without

compromising quality and inspire and motivate others to do the

same. Able to deal with a range of scientific disciplines and

lead them when necessary. Possesses integrity and the ability to

inspire trust and confidence. Good negotiation, written and

verbal communication skills. Skilled in analyzing issues and

presenting both written and oral evidence. Able to write clearly

and summarize data effectively. Possesses an attention to

detail. Requires minimal supervision. Good Computer skills.

Proficiency with Word, Adobe, Power Point and Excel. Proficiency

with Enginuity, Agile, Blue and SharePoint databases.

Education Ramapo college of New Jersey Bachelor of Science in Biology,

1986

Energizer Personal Care September 2013 to

September 2014

Regulatory Specialist

Prepare regulatory submissions to health authorities in North America,

assuring submissions meet relevant regulatory requirements.

Communicate with regulatory agencies regarding compliance clarification and

follow up of submissions under review.

Create and update Standard Operating Procedures and Work Instructions to

improve internal processes.

Track product registrations in North America, to amend current registrations

of cosmetics and OTC drugs.

Track product discontinuations in North America, to cancel registrations of

cosmetics and OTC drugs.

Prepare Drug Identification (DIN) applications to register new OTC Drugs with

Health Canada.

Submit Drug Notifications to Health Canada for OTC drugs.

Prepare Cosmetic Notifications and submit to Health Canada.

Submit Annual Drug Notification to Health Canada.

Maintain Medical Device Licenses for Health Canada.

Perform facility registrations for North America with the FDA.

Review label materials for North America to ensure applicable internal and

regulatory requirements are met.

Review product changes for North America to determine impact to existing

labeling

Review raw materials for compliance with FDA food contact requirements and

other U.S state requirements.

Maintain U.S. bedding licenses for infant care products.

Collaborate with R&D and Marketing to help meet required deadlines and

regulatory compliance.

Research and monitor new regulatory requirements for consumer products to help

ensure that products remain in compliance.

State License Servicing August 2011 to September

State Licensing Specialist 2013

Preparation of pharmaceutical license applications and renewals of to state

licensing boards.

Service existing clients pharmaceutical license portfolio's by making

necessary amendments to their

Current state licenses.

License new facilities with state licensing boards.

Keep clients license portfolio's compliant with each state licensing boards

individual requirements.

Warwick Valley School

Tutor -Present

Provide supplemental instructional strategies to assist students in grades

K-12 academically

Evaluate student progress and modify teaching style if necessary

Collaborate with the school supervisors, teachers and staff members

Biocraft Laboratories October 1987- September

Manager of International Submissions 1994

September 1993-September 1994

Determine regional regulatory requirements to ensure compliant submissions to

Regulatory Agency

Track, identify and communicate trends in regional regulatory requirements

Collect and evaluate scientific data for submission to Regulatory Agency

Preparation of compliant submissions and documents to regional Regulatory

Agency

Act as a liaison between the company and regional regulatory agency to gain

approval of submissions

Design templates for future international submissions

Product Coordinator GHB

September 1989-September 1993

Helped design and Monitor Phase I clinical trial

Provide regulatory support for product development

Liaison between the company and regulatory agency in negotiations necessary

to gain approval of drug

Regulatory Submissions Coordinator

October 1987- September 1989

Preparation of compliant submission of ANDAs to the FDA

Preparation of all supplements and amendments to the FDA

Plan and coordinate bioavailability studies and clinical trials

Collect and evaluate scientific data for submission to FDA

Responsible for inspection of clinical laboratories used by the company

Responsible for monitoring all bioavailability studies and clinical trials

Highlight: Helped design and monitor Sucralfate clinical trial

Ayerst Laboratories

January 1987 - October 1987

Medical Associate

In house monitoring of Phase II and Phase III clinical trials

Memorial Sloan Kettering Institute

December 1985 - January 1987

Research Technician

Maintain cell lines in culture

Extract and purify antigens

Becton Dickinson Immunodiagnostics

May 1983 - December 1985

Quality Control Technician

Analyze and test all incoming raw materials as to company specifications

Approve new raw material vendors

Evaluate customer complaints

Conducted stability testing on finished products

Competitive Analysis

Debi Parker

Debi Parker

22 Somerset Lane "

Warwick, NY 10990

845-***-****

dlparker@oerset Lane . Warwick, NY 10990

845-***-****

ablld9@r.postjobfree.com

Contact this candidate