Manager, Regulatory Operations Job

Employer Name: BiotechCrossing	SpiderID: 2385133
Location: Gaithersburg, Maryland	Date Posted: 7/22/2008
Wage:	Category: Biotech
Job Code: 6640464

Job Description:
Position Title: Manager, Regulatory Operations Department Name: Regulatory Affairs Location: Gaithersburg,MD Req Number: 00873 Provides guidance to the organization with respect to electronic and paper submission requirements by working with Regulatory Affairs and project teams, to gather, interpret, and support implementation of submission requirements. Implements regulatory submission publishing and production procedures in addition to publishing documents. Major Duties and Responsibilities: Manages submission publishing activity tasks including production and QC Liaises with Regulatory Affairs and IT partners to ensure the appropriate development of systems, prioritization of issues and training of individuals within the organization on issues pertaining to submission publishing Provides expertise to product teams on the application of electronic submission requirements to their specific submissions Manages compilation of submission outlines and assembly of electronic submissions Coordinates updates and problem-solves issues related to publishing software Monitors agency environment with respect to new guidance and regulations on electronic submissions and subsequently works with the organization to implement changes Collects and interprets global electronic submission guidelines Manages the design and implementation of electronic publishing standards Ensures the organization has the capability to implement fully electronic submissions and is viewed as an industry leader in this technology Works with the organization to implement regional regulations/guidance\'s for electronic submissions and electronic signatures Represents Regulatory Operations on EDMS User Team.

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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: BiotechCrossing

City: Pasadena
State: California
Zip:

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