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| Employer Name: BiotechCrossing |
SpiderID: 2451867 |
| Location: Gaithersburg, Maryland |
Date Posted: 8/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 7600457 |
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Job Description:
Responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with project team members and partners for submission of Investigational New Drug Applications and Biologic License Applications and maintenance of applications and licenses. Major Duties and Responsibilities: 1. Develops regulatory strategy for all phases of drug development for biologic investigational and post approval products. 2. Monitors product-related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices. 3. Communicates and manages regulatory commitments resulting from discussions with regulatory authorities to ensure appropriate and timely implementation. 4. Represents Regulatory Affairs on Research, Development, Clinical, Manufacturing and Quality Project Team meetings to provide regulatory guidance and support. 5. Interacts with responsible departments and manages collection, review, and assembling of the scientific, clinical, manufacturing, and administrative sections of submissions to regulatory agencies. Interacts with other project team members to ensure the timely and comprehensive receipt of information required for regulatory submissions. 6. Reviews all supporting documentation required in regulatory applications for accuracy and completeness and determines the applicability of supporting documentation for inclusion in regulatory submission.
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For further information, please visit us online at http://www.biotechcrossing.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: BiotechCrossing |
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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.biotechcrossing.com
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