|
|
|
|
Manager, Regulatory Operations Job
|
| Employer Name: BiotechCrossing |
SpiderID: 2388292 |
| Location: Gaithersburg, Maryland |
Date Posted: 7/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6640464 |
|
Job Description:
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 Manages contract staff in the preparation of legacy electronic and paper documents in accordance with FDA and ICH CTD requirements for inclusion in the electronic document management system. Assists the Associate Director, Regulatory Operations in all areas of responsibility, including interpreting and enforcing paper and electronic regulatory submission standards, policies and operating procedure requirements.
For more information, please click here to visit us at BiotechCrossing
For further information, please visit us online at http://www.biotechcrossing.com
Sign Up Now
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
|
|
|
|
|
|
|