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Manager/Director Pediatric Vaccines, North American Regulatory Affairs
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Manager/Director Pediatric Vaccines, North American Regulatory Affairs : GlaxoSmithKline
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| Job Number |
53978 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
6 to 9 Years |
| Start Date |
5/11/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Required Degree |
Bachelors Degree |
| Relocation |
Not Required |
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| Description |
Basic Qualification
Bachelors degree (Science), At least 6-7 years (grade dependent) relevant experience in Vaccine Development and or Vaccine Regulatory Affairs experience
Scientific background
Organizational skills
Written and oral communication skills
Ability to strategize, problem solve and influence in matrix team setting
Demonstrated knowledge in regulatory affairs and vaccine clinical development or equivalent
Details
Development Strategy for pediatric vaccines for US Market
Responsible for proposing plans and managing technical and, as appropriate, clinical regulatory aspects of development and strategic plans leading to regulatory approvals and life cycle management for marketed vaccines ; consolidate, communicate and maintain current regulatory plans ensuring alignment with Head, Pediatric Regulatory Affairs, Vaccines. Includes direct, primary liaison with internal and expernal customers.
Experience in providing strategic advice on integrated development plans and problem solving in cross-functional teams.
•Scientific and regulatory knowledge pertinent to CMC and clinical development aspects of biologics is preferred.
•Experience in liaison with major regulatory Agencies, preferably US FDA |
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| Requirements |
Preferred Qualification
Masters Degree Preferred
•Significant experience in Vaccine development – US focus
•Experience/exposure to global RA development and regulatory requirements
•Significant presence to external industry and scientific organizations
Previous direct experience with FDA |
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