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Regulatory Affairs Project Manager Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2373753 |
| Location: Minneapolis, Minnesota |
Date Posted: 7/16/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6517093 |
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Job Description:
Manages the regulatory aspects of projects/products, including major, complex applications submitted to regulatory agencies. Ensures that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Develops effective regulatory strategies for new products and communicates such strategies to the appropriate Team Leader, Team Members and/or supervisor, with limited oversight. Interfaces directly with governmental regulatory personnel, including scientific reviewers, administrative staff and management, to facilitate the review and approval of regulatory applications. Reviews documentation from departments outside Regulatory Affairs with very limited oversight. Provides advice as to regulatory acceptability of plans for drug development, CMC, labeling, advertising/promotion through individual as well as RA Team and Interdepartmental Project Team contacts. Provides interpretive analyses of complex regulatory guidance documents, regulations, or directives as they pertain to Paddock products. Remains current and knowledgeable regarding relevant regulations and regulatory practices as expressed through regulations, regulatory guidances, and other government publications, industry trade publications, and industry conferences. Minimal travel is expected for this position.
For more information, please click here to visit us at PharmaceuticalCrossing
For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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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 |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.pharmaceuticalcrossing.com
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