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Regulatory Project Manager Job
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| Employer Name: Vanara |
SpiderID: 2309414 |
| Location: Durham, North Carolina |
Date Posted: 6/23/2008 |
| Wage: |
Category: Management |
| Job Code: KB8H3475 |
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Job Description:
 A biopharmaceutical company seeks Regulatory Project Manager with 7-10 years of relevant experience. The candidate will develop and maintain detailed timelines for cross-regional regulatory activities and submissions for specific therapeutic areas, and assure planning and co-ordination of activities. Track regulatory commitments and timelines for maintenance activities such as annual reports, license renewals, postmarketing commitments, and follow-up measures, and assuring appropriate submissions are made in accordance with applicable requirements and deadlines. Contributing to the preparation of moderately complex regulatory submissions which require interaction with departments outside of regulatory affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Responsible for managing activities toward submission of moderately complex regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories. Plans, schedules and arranges own activities and may direct others in accomplishing objectives. The candidate should have B.A. degree in relevant discipline and 8+ years of relevant experience in regulatory affairs or related field. An advanced degree is desirable. Previous supervisory experience is desirable. The ideal candidate should have experience in both regulatory affairs and project management. Experience in the area of antiviral drug products is appreciated. Direct experience working with regulatory authorities in assigned territories is desirable. Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for assigned territories. May take a supportive role in updating and preparing the company for minor changes in legislation in assigned territories.
For further information, please visit us online at http://www.vanara.com
Please send your resume to Law Firm Staff at jobs@vanara.com
Apply Now
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Carleen Trapp |
Company Type: Recruiter |
| Company: Vanara |
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| City: Ephraim |
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| State: Utah |
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Web Site: http://www.vanara.com
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