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Director, Regulatory Affairs Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2348971 |
| Location: Bannockburn, Illinois |
Date Posted: 7/7/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
The position responsibilities also include serving as a secondary liaison with regulatory agencies regarding quality systems and compliance policies and will be located in the new Chicago office. The position will be located in the new Chicago office and is expected to evolve into a supervisory position as the company advances development and commercialization of its leading compounds. Thus, the ideal candidate would have management and mentoring experience and would be expected to inspire and motivate, and to serve as a role model for reports and colleagues. Key Responsibilities: Contribute in proactively formulating global regulatory strategies that interpret and reflect regulatory and corporate guidelines Plan, manage and implement regulatory programs into multidisciplinary project teams for all products from late-stage development through commercialization Represent Cytochroma at FDA, DDMAC and other regulatory agencies Initiate and respond to regulatory agency contacts (e.g. telephone, email, written, meetings) to negotiate successfully with regulatory agencies to achieve business objectives Responsible and accountable for regulatory review of promotional materials and for ensuring regulatory compliance of product brand Review global product promotional materials and press releases Ensure that all documents to be submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality in such a way as to facilitate review Assist with the technical transition from pre-approval research to post-approval commercial phaseational
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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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