Regulatory Operations Technician Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2341046
Location: North Wales, Pennsylvania	Date Posted: 7/4/2008
Wage:	Category: Medical/Health
Job Code: 6029704

Job Description:
This exciting opportunity will be part of a team of specialists providing submission ready structure in CTD/eCTD format for all Regulatory submissions to the FDA. Responsibilities: Prepare Annual reports in accordance with FDA regulations, maintain current Annual Reports, and fulfill accurate tracking reports with the use of electronic records. Track documentation for Regulatory submissions once approved. Track correspondence to and from the FDA and relay information to the necessary internal departments to assist in problem resolution in a timely fashion if required. Pagination, copying, disk creation/copying, creating book labels, etc. for each submission type Research, prepare, finalize, and track Annual Reports Complete supplements, amendments and other FDA submissions in accordance with FDA guidelines Maintain various tracking reports/databases Copying of correspondence as requested by other departments Provide backup administrative support as needed (phone coverage, distribution of mail, faxing, and filing, etc) Qualifications: Associates degree, strongly preferred Minimum 2 years relevant office experience Proficiency in MS Office (specifically Word, Excel, Access) and Adobe Acrobat Strong typing and computer skills Good internet research skills.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com