Toni Glinsey

Country Club Hills, IL

currently: Job hunting


Answers from Toni

What kind of job are you looking for?

I, Toni A. Glinsey, am currently a Supervisor of Regulatory Affairs responsible for the management of Corporate and Manufacturing Plant Regulatory Affairs Scientists. I am seeking a new employment opportunity that will afford continued growth and responsibility for the effective management of a team of professionals responsible for the submission of high quality documentation to the regulatory authorities. Additionally, I would like to continue to provide regulatory strategy to the RA team and other business disciplines to achieve optimal regulatory submission efficiency and Agency review time. Furthermore, the position should hold the responsibility for effective negotiation with Agency to achieve expedited development, filing, and regulatory approval for new and marketed products. I am certain that my work experience and knowledge will grant the capacity necessary to achieve success in these areas.... read more

Posted @ 10:26AM, July 04, 2007 by Toni Glinsey | Permalink
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Work history

Abraxis Pharmaceutical Products August 2002 to the present
Supervisor, Regulatory Affairs

tags:

How would you describe your time at Abraxis Pharmaceutical Prod...?

* Build and maintain a collaborative relationship with FDA by interfacing with reviewers, division heads, etc. (as appropriate) and negotiating resolution of regulatory issues affecting product development
* Develop effective proactive regulatory strategies/Negotiate complex regulatory issues
for product development and earliest market approval, and recommend such strategies to team members and management
* Provide strategic RA guidance to APP business disciplines regarding desired revisions to products as well as the rectification of product issues that may arise
* Provides guidance to team for the preparation and filing of high quality submissions to regulatory authorities, such that all applications are filed in accordance with predetermined timelines and only minor FDA deficiencies are received
* Manage and prioritize the team's workload in accordance with the goals established by senior management
* Participate in the hiring, training, and management of direct reports to ensure successful performance and career growth
... read more
TAP Pharmaceutical Products Inc. (TAP) April 2001 to August 2002
Regulatory Affairs Specialist

tags:

How would you describe your time at TAP Pharmaceutical Products...?

* Interact with R&D and business units to provide regulatory strategy and support for drug development projects to insure the timely submission, approval, and registration of new products/indications and maintain approval for marketed products
* Prepare and file IND/NDA/eNDA submissions and
other regulatory documents with the FDA while simultaneously training more junior colleagues
* Insure product quality, manufacturing efficiency, and provide regulatory strategy/support for drug development
* Define regulatory requirements and review the completeness and accuracy of data submitted by project team members for inclusion in regulatory submissions to the Agency
... read more
Regulatory Affairs Manager

tags:

How would you describe your time at Sarawak MediChem Pharmaceut...?

* Prepare, review, release, and file regulatory documents and drug applications with the FDA, in accordance with cGMPs
* Act as a sponsor representative for clinical site initiation and close out visits/Monitor ongoing clinical and non-clinical studies
* Create strategic formulations for an
acceleration of patient enrollment, dose range achievement, and protocol completion
* Assist in the location and coordination of non-clinical and clinical trial sites, contract research organizations, and consultants
* Compile Chemistry, Manufacturing and Control (CMC) sections for initial IND application filling for internal investigational drugs as well as those from contracting companies and audit contracting manufacturing facilities
... read more

Education

University of Illinois (Chicago) August 2003 to the present
Biostatistics

How would you describe your time at University of Illinois (Chi...?

Currently pursuing a MPH degree
University of Illinios (Champaign~Urbana) August 1993 to December 1997
Biology

How would you describe your time at University of Illinios (Cha...?

Received a Bachelor of Science Degree

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