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Director, Regulatory Affairs Job
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| Employer Name: BiotechCrossing |
SpiderID: 2197807 |
| Location: Cambridge, Massachusetts |
Date Posted: 4/21/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
This person is responsible for regulatory documents and submissions, represents the company with regulatory authorities, contractors, and corporate partners. The director provides regulatory support for various departments including commercial business units, public relations, investor relations, drug safety and risk management, clinical development teams and supply chain. Essential functions include:à ? Provide regulatory guidance to cross-functional teams that establish strategy and vision for promotional materials, sales training materials, press materials, and other external communications.à ? Establish regulatory strategy and tactics for developing core labeling documents and draft labeling for regulatory authority review and approval and for maintaining labeling and core labeling documents throughout development and commercialization.à ? Provide leadership for effective decision-making, planning, and project management in the development and maintenance of labelingà ? Direct development and maintenance of product labeling assuring cross-functional input.à ? Influence regulatory authorities, professional organizations, and colleagues at all levels through effective communications and presentations.à ? Demonstrate effective cross-functional and cross-cultural skills and foster a gloval view as part of the regulatory team.à ? Develop and maintain highly capable and dedicated regulatory staff. Guide direct reports in carrying out responsibilities. Responsible for coordinating activites and career development of direct reports.à ? Build and maintain excellent relationships with regulatory agencies, with particular focus on DDMAC, OSE, and other functions with FDA that have particular relevance to labeling and communications.
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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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