Senior Associate/ Manager Regulatory Operations Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2398007
Location: Cambridge, Massachusetts	Date Posted: 7/26/2008
Wage:	Category: Medical/Health
Job Code: 6833809

Job Description:
DUTIES & RESPONSIBILITIES Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines. Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management. Identify issues that may delay product or project and recommend appropriate action. Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology. Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity. Prepare and maintain templates that meet Regulatory electronic submission standards. Assist in establishing electronic submission capability at Millennium, focusing on implementing the eCTD and representing Regulatory business function on technology teams. Manage compliance-related submissions and activities.

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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