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Senior Regulatory Affairs Project Director Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2367945 |
| Location: Silver Spring, Maryland |
Date Posted: 7/14/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6458529 |
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Job Description:
The individual will be responsible for (1) developing and implementing project management systems (2) ensuring the best use of resources for the efficient operation of the project; and (3) that the regulatory team meets required schedules. In addition, the individual will be responsible for the following: (1) ensuring that the regulatory team resolves issues in dealing with regulatory authorities (FDA, Health Canada, European Union regulatory authorities); (2) providing regulatory compliance in support of new or modified pharmaceutical products and/or combinations products; (3) ensuring that QA systems are in place for the administrative and technical review of, and actions on regulatory related materials; (4) providing cGCP and GXP training to government staff, investigators, and clinical site staff; (5) overseeing the management of specialized expertise support services; (6) and ensuring that required QA, GXP audits are accomplished. Minimum requirements include a PhD or equivalent in biomedical or life sciences; strong leadership skills and the ability to establish sound working relationships with staff and the client; supervisory management experience; strong knowledge and direct experience in FDA submission and approval processes; a minimum 10 years of hands on experience related pharmaceutical experience and regulatory drug/biologics and device development experience; experience and knowledge of current FDA, Health Canada, and European Union regulatory authorities\' requirements and industry standards; and excellent verbal and written communication skills SSS offers an excellent compensation and benefits package, including 4 weeks of paid leave, health benefits, 401K, and ten paid holidays a year. SSS is an employee-owned company.
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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