Quality Assurance Project

Elizabeth Docherty, RAC 610-***-**** **********@*****.***

Objective

Regulatory Affairs liason position facilitating product development and registration by developing and executing regulatory strategies and effective regulatory agency interactions throughout product lifecycle; thereby making safe and effective healthcare products available to consumers on a timely basis.

Profile

Self motivated, detail oriented professional with exceptional multi-tasking ability, organizational, interpersonal, verbal and written communication skills, and management experience working with both projects and staff.

7+ years Pharmaceutical Industry experience with US RAC Certification, detailed knowledge of and direct experience in US Regulatory Affairs in the preparation of major regulatory submissions and supportive amendments and supplements.

Education

TEMPLE UNIVERSITY – Fort Washington, PA

Quality Assurance/Regulatory Affairs

Master of Science Degree, anticipated completion in 2011

Drug Development Certificate, 2009

CEDAR CREST COLLEGE – Allentown, PA

Genetic Engineering Major, Chemistry Minor

Bachelor of Science Degree, summa cum laude, 2000

Professional Experience

B. BRAUN MEDICAL INC., ALLENTOWN, PA

REGULATORY AFFAIRS

SPECIALIST JULY 2008-PRESENT

Schedule, coordinate, prepare, and review New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), amendments, supplements, annual reports and general correspondence to NDA/ANDAs in eCTD format and in cooperation with project team members, ensuring full compliance with agency requirements while meeting tight deadlines to gain timely approval.

Independently correspond with FDA to request meetings, discuss agency comments, and follow-up on submissions.

Utilize technical knowledge and effectively apply regulations and guidelines to determine filing strategy and documentation requirements associated with post approval change controls.

Review and provide constructive comments on key documentation such as specifications, manufacturing procedures, validation protocols, and stability reports.

Provide daily direction and training to RA Senior Associate regarding all aspects of review, submission, and maintenance of NDA/ANDAs and Drug Master Files (DMF).

GLAXOSMITHKLINE, COLLEGEVILLE, PA

ONCOLOGY DISCOVERY TECHNOLOGY GROUP

SENIOR SCIENTIST SEPTEMBER 2006-JUNE 2008

• Deliver molecular and cell biology support to identify/validate new targets and biomarkers for the Oncology Center of Excellence in Drug Discovery’s programs and pipeline. Representative in the “Gene Expression Best Practice Workgroup” to enable platform excellence and protocol consistency transnationally.

DISEASE & BIOMARKER TRANSCRIPTOMICS

SENIOR SCIENTIST MARCH 2005-AUGUST 2006

SCIENTIST OCTOBER 2003-FEBRUARY 2005

ASSOCIATE SCIENTIST OCTOBER 2001-SEPTEMBER 2003

• Utilize Affymetrix microarray experiments for compound characterization, target identification, and validation to support therapeutic area initiatives within GSK.

• Validate and implement new protocols and lean lab concepts to reduce expenses, increase productivity, and expand the department’s capabilities in processing new sample types; communicate with transnational counterparts to align processes/use scientific expertise to troubleshoot and solve project related problems.

• Implement Nautilus Laboratory Information Management System (LIMS) transnationally. Rewarded with several scientific impact awards for contributions with regards to data integrity initiatives and human tissue audit compliance.

• Oversee daily lab activities including sample acquisition/storage/processing, project acquisition and delegation, QC control, report completion, SOP protocol implementation, lab supplies/capital equipment ordering and budget management, equipment upkeep, and implementation of electronic laboratory notebook.

• Supervise up to 6 employees simultaneously; train new employees in experimental design and relevant laboratory techniques.

UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA, PA

LABORATORY OF DR. LEWIS CHODOSH

RESEARCH SPECIALIST JUNE 2000-SEPTEMBER 2001

• Assess differences between normal and oncogenic gene and protein expression during the development of the mouse mammary gland in different transgenic and knockout systems.

• Independently manage and operate the use of Affymetrix Gene Chip equipment for the Microarray Core Facility.

ROHM AND HAAS COMPANY, SPRING HOUSE, PA

LABORATORY OF DR. DEAN CRESS

INTERN AUGUST 1999-MAY 2000

• Utilize standard molecular cloning and cell culture techniques to evaluate the ecdysone receptor gene switch function in mammalian and yeast cells.

Publications and References Available Upon Request

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