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Senior Regulatory Affairs Manager Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2359087 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/10/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6300088 |
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Job Description:
ChimeriVax-JE, which is undergoing Phase 3 clinical testing, ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing and is the most advanced investigational vaccine against the West Nile virus, and the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. Acambis is recognised internationally as the leading producer of smallpox vaccines, which it manufactures for emergency-use stockpiles for the US Government and other governments around the world. Acambis is listed on the London Stock Exchange (ACM). Our Cambridge office in Massachusetts is currently looking for a Senior Regulatory Affairs Manager. The candidate will establish regulatory strategy, coordinate regulatory activities for assigned project(s) and monitor the regulatory environment for changes that could impact product development. Job Responsibilities: • Interface with Regulatory Agencies, answering regulatory questions. • Provide regulatory guidance to functional areas. • Interface with Acambis industry partners to address regulatory issues. • Regulatory CMC oversight of investigation and commercial vaccine products. • Ensure rapid and effective development and review of regulatory documents to be submitted to the FDA and international regulatory agencies. • Coordinate with preclinical, clinical, medical affairs, manufacturing and quality systems groups to ensure regulatory submissions are reviewed and approved to meet project target dates. • Develop, implement, and adjust, as needed, regulatory strategies during the development phases of the assigned project(s). • Coordinate comments to draft guidelines and provide Regulatory Department's interpretation of guidelines to functional areas, as needed.
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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Web Site: http://www.pharmaceuticalcrossing.com
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