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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2350765 |
| Location: Nutley, New Jersey |
Date Posted: 7/8/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6197140 |
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Job Description:
Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves. The Position:1. Provides regulatory strategic direction related to chemistry, manufacturing and controls to the regulatory and/or technical leader(s) and their respective global development team or US product team. 2. Takes a leadership role, as appropriate, on project team(s) and within the function to resolve critical issues and meet business objectives. 3. Serves as a principal interface with FD A CMC reviewers and directs FD A interactions with technical teams. Develops CMC regulatory strategies and prepares associated regulatory submissions. 4. Coordinates activities of global PDR personnel and cross-functional teams to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines. 5. Proactively and independently manages special regulatory projects of high complexity. 6. Mentors PDR personnel and updates appropriate departments on current regulatory environment.Who you are:1. MS degree or B A /BS and scientific research experience 2. 5+ years relevant experience in drug development and regulatory affairs 3. Expert knowledge of core processes in pharmaceutical development: discovery, development, manufacturing, and marketing 4. Excellent communication and organizational skills.
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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