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Association Director Regulatory Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2377309 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/17/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6558692 |
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Job Description:
This position entails participation on various cross functional project teams, strong interaction with Technical Operations personnel at manufacturing sites and other key partners both internal and external to the company. The position will have responsibility for providing global regulatory assessments for anticipated analytical, manufacturing and packaging changes, compilation of post approval regulatory submissions including annual reports, renewals, supplemental applications, variations and other maintenance dossiers and coordination of responses to health authority questions comments. This position requires the ability to manage multiple projects and to prioritize work independently. This position will interact directly with the FDA and with other Health Authorities through local regulatory managers with minimum management participation. Position Requirements: 8+ years in the Pharmaceutical Industry and 4+ years biologics CMC regulatory strategy or related experience. The preferred candidate will have a strong knowledge of global CMC regulations and guidance's pertaining to biologics, exposure to developing global regulatory strategies for post approval changes, and direct experience in handling health authority questions and responses. The candidate should have an understanding of the pharmaceutical business and experience in building favorable relationships with key partners.
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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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