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Apply online for the
Manager/Director RegulatoryAffairs, CVM
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Pharmaceutical industry today.
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Manager/Director RegulatoryAffairs, CVM : GlaxoSmithKline
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| Job Number |
53830 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Philadelphia
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
4/24/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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| Description |
Basic Qualification
Bachelors degree in a health science or biological science.
5 years of relevant work experience and will have gained operational knowledge of IND and NDA regulations, including regulatory requirements governing advertising and promotional labeling.
Details
Provide US regulatory affairs expertise to assure that marketed drug products comply with post-approval regulatory requirements, including advertising and promotion review.
Provide US regulatory affairs expertise to multidisciplinary teams in order to facilitate timely and efficient development of investigational drug products.
Responsibility for a range of regulatory submissions, including resolution of regulatory issues and questions.
Assure compliance of submissions with applicable laws, regulations, and other requirements of FDA and other applicable agencies.
Collaborate with USRA Operations, CMC Regulatory Affairs, CEDD Regulatory Affairs, and Compliance to facilitate teamwork, communication, and efficiency throughout USRA. |
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| Requirements |
Preferred Qualification
Graduate degree in a health science or biological science is preferred. Ideally the candidate will have at least 5 years of relevant work experience and will have gained operational knowledge of IND and NDA regulations, including regulatory requirements governing advertising and promotional labeling. Experience of development or support of products in the Cardiovascular and Metabolic area and regulatory agencies outside the US would also be of value.
The candidate should be able to demonstrate the following skills:
•Proven ability to work constructively as part of a multidisciplinary team.
•Ability to multi-task on time-sensitive activities in parallel.
•Flexibility and willingness to dynamically prioritize activities.
•Use of sound logic and problem solving skills.
•Record of valued interpersonal, verbal and written communication skills. |
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