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Manager CMC Regulatory and Compliance Job
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| Employer Name: EngineeringCrossing |
SpiderID: 2346160 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/7/2008 |
| Wage: |
Category: Engineering |
| Job Code: 5907529 |
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Job Description:
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. With management participation, this position will interact directly with the FDA and with other Health Authorities through local regulatory managers. EDUCATION PREFERRED Minimum BS, Chemical Engineering, Pharmacy, Chemistry, Biology or related science. An advanced degree is an asset. YEARS OF EXPERIENCE PREFERRED 5+ years in the Pharmaceutical Industry and 3+ years biologics CMC regulatory strategy or related experience in biologics analytical development or manufacturing. LIST MAJOR SKILLS REQUIRED The preferred candidate will have a strong knowledge of global CMC regulations and guidances 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.engineeringcrossing.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: EngineeringCrossing |
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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.engineeringcrossing.com
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