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Regulatory Scientist Back to search
Contact Information:
Sunrise Systems Inc
PO BOX 4647
Metuchen, NJ 08840
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Contact: 
Phone: 
Fax: 
Badar Ansari
7326032200
7326032208

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Reference Number:
BA_RegS

Job Description:
A leading Fortune 500 Client of ours is looking for a Regulatory Scientist based in West Point, PA

Qualifications:

Prepares the chemistry, manufacturing, and controls information for worldwide marketing of pharmaceutical products (NDA, WMA, CTD) to include annual reports, registration renewals, supplements / variations, INDs/CSAs, and responses. Interfaces with Registration Managers on post-approval changes, performs tracking and follow-up and performs routine assignments to support a product / product franchise. Adheres to requirements for use of new and existing CMC systems (PCR, ACR, CoreWMA, PMD, ORION, WMCS)

Responsibilities:

Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline preferred. Prior industry experience, particularly within the CMC field is preferred. Effective oral and written communication skills. Working knowledge of WORD and EXCEL and Documentum. Innovative, flexible and collaborative. Effective problem solving and decision making skills. Able to manage multiple projects.

Experience Level:
Unspecified

Requirements:
Email your resume in MS Word format to badar@sunrisesys.com

Location:
West Point PA

Duration:
6 - 9 months

Pay Rate:
DOE

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Date Posted: 11/17/2009
Last Updated: 11/17/2009
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