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Senior Director / Executive Director / VP Regulatory Affairs Job
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| Employer Name: BiotechCrossing |
SpiderID: 2247851 |
| Location: Boulder, Colorado |
Date Posted: 5/31/2008 |
| Wage: |
Category: Biotech |
| Job Code: 4940800 |
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Job Description:
Collaborative team player that can establish and maintain effective working relationships with other departments, the FDA, and outside vendors Excellent interpersonal skills with knowledge of negotiations, influencing and conflict management to assure effective interactions within and across departments Proficiency with Word, Excel, PowerPoint is required Ability to contribute extensive regulatory expertise and advice across multiple areas Maintains awareness and understanding of the impact of existing and forthcoming regulatory legislation within the context of biotech industry issues Results orientation, sense of urgency, sound judgment and attention to details Must be flexible and able to effectively manage multiple competing priorities. They will have a direct role in drafting, reviewing and administering regulatory strategy and policy throughout the drug development process and to effectively negotiate with regulatory authorities. The candidate must be credible, influential, and a respected corporate spokesperson for interactions and negotiations with regulatory authorities and agencies. Establish and communicate regulatory policy to internal customers and provide clarity concerning regulatory expectations, regulatory submissions, and final corporate drug development reports and regulatory submission documents submitted for approval Advise on strategies necessary to optimize drug development programs Conduct regulatory due diligence on external business opportunities. Proactively interacts with FDA and international regulatory agencies, identifying issues and solutions, and communicates outcomes and status to senior management as appropriate.
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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Web Site: http://www.biotechcrossing.com
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