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Regulatory Affairs Senior Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2247840 |
| Location: Thousand Oaks, California |
Date Posted: 5/31/2008 |
| Wage: |
Category: Biotech |
| Job Code: 4985239 |
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Job Description:
This would involve development and management of regional regulatory and safety personnel based in regional hubs, support with evaluation of preferred regulatory vendors to support the Functional Service Provider model, support pre- and post-marketing activities, clinical trial related activities and local regional regulatory policies. Responsibilities would include directing innovative international regulatory strategies for product development and approval (small molecule and biologics); provide regulatory support for key customers and stakeholders; and manage direct reports and external vendors/contractors. This position reports to the Executive Director. Evaluates new and revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.- Maintain expert knowledge in product specific Asia Pacific and Latin American regulatory requirements and be a point for local/regional registration strategies- In a leadership role supervise staff, oversee external vendor/contractor relationship- Support to develop and implement Asia Pacific and Latin America multinational registration and compliance strategies of new and current products, taking into account current and proposed changes in registration requirements, technical methods and standards.- Ability to influence and motivate others outside of direct line of authority- Demonstrated ability to manage several complex projects in parallel- Strong sensitivity for a multicultural/multinational environment.- Knowledge of eCTD- Strong computer literacy, including word processing, presentation, and spreadsheet applications.
For more information, please click here To visit us at BiotechCrossing.
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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