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Director Regulatory Affairs Job
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| Employer Name: BiotechCrossing |
SpiderID: 2217377 |
| Location: Thousand Oaks, California |
Date Posted: 5/8/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Provide guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional approval, compassionate use and pediatric plan)- Provide input into SCD, study protocols, statistical analysis plans, clinical study reports and other documents used to support product development and registration- Participate in the development of product label and core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.- Provide leadership for planning and implementing regulatory filings i.e. FIH, CTD, label extensions- Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan- Monitor and assess impact of relevant global regulations, guidance's, current regulatory environment and competitor labeling- Ensure effective regulatory agency communications by chairing core regulatory and cross functional teams- Lead GRT to develop and execute team goals- Ensure creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communications- Ensure global consistency of evidence-based product communication.
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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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