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Manager, CMC Regulatory Affairs, USRA, Vaccines
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Manager, CMC Regulatory Affairs, USRA, Vaccines : MedImmune
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| Job Number |
57610 |
| Employee Type |
Full Time |
| Company Name |
MedImmune |
| Location |
King of Prussia
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
1/26/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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MedImmune
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| Description |
Basic Qualification
• Strong scientific background
• Excellent organizational skills
• Excellent written and oral communication skills
• Ability to strategize, problem solve and influence in matrix team setting
• Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent
Details
Responsible for proposing plans and managing CMC regulatory aspects of development and strategic plans leading to US approvals and life cycle management for assigned projects; consolidate, communicate and maintain current regulatory plans ensuring alignment with Head Therapeutic Area Regulatory Affairs
Responsible for managing CMC regulatory aspects of US filing strategies for IND, BLA and supplements for assigned projects
Responsible for liaison for CMC RA with FDA reviewer level staff
Responsible for data-driven messaging, content and format of CMC submissions and ensure readiness of documentation for review within Therapeutic area of USRA , includes planning of desired documentation, review and revision of drafts and resolution of content issues with USRA supervisor, RA Central/data-generating groups in all Project Teams for assigned projects
Acts as representative in interactions with USRA Operations planning and publishing teams, with US Labeling group and with multifunctional US Label Review Teams providing CMC support, advice and preparations of deliverables for assigned projects with oversight of Head Therapeutic Area
Acts as representative/provides strategic regulatory and operational copy approval support to US business and marketing teams for pertinent CMC aspects for assigned therapeutic area in agreement with Head Therapeutic Area, USRA
Contributory role in interactions with US Policy Groups as needed and in review and official comment to FDA on proposed draft Guidance and exertion of influence in keeping with appropriate vaccine development and GSK position. |
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| Requirements |
Preferred Qualification
• Significant experience in Vaccine/Biologic Clinical aspects of Regulatory Affairs or development
• Significant presence in/contributions to external organizations pertaining to regulation of product development preferably vaccines/biologicals
• Interest/experience in cross-training in clinical aspects of RA is desirable |
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