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Regulatory Affairs Associate
position and advance your career in the
Pharmaceutical industry today.
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Regulatory Affairs Associate : MedImmune
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| Job Number |
57428 |
| Employee Type |
Full Time |
| Company Name |
MedImmune |
| Location |
Parsippany
New-Jersey
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
1/15/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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MedImmune
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| Description |
Basic Qualification
• BS/BA degree in science field required.
• A minimum of 5 years experience in the pharmaceutical industry required.
• Good written and verbal communication skills required.
• Ability to prioritize activities and issues.
• Awareness and ability to work within areas of cultural differences.
• Knowledge and ability to use IT software technology.
Details
Provide operational and strategic support to Future Regulatory Affairs Teams responsible for development of products in smoking control category:
1) Interact and collaborate with the multi-disciplinary teams to implement development, registration, and marketing strategies for assigned products and projects.
2) Contribute to the development of global regulatory strategies.
3) As directed by the Category team Leader, coordinate the preparation and submission of regulatory filings.
4) Critically review internal and external submission documents.
5) Act as central RA coordinator for local RA functions, globally, for specific projects and products.
6) Collaborate with GSK functional areas to support prompt and effective preparation of global submissions.
7) Participate on project teams as required,
8) Perform regulatory review of labeling, claims and advertising, change controls for specific products/projects. |
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| Requirements |
Preferred Qualification
• Proactive attitude to process improvement is also highly desirable.
• 2-3 years experience in Regulatory Affairs or at least 5 years experience in a related profession.
• Regulatory experience with OTC drugs (Monograph and NDA).
• Experience with cosmetics, medical devices, and dietary supplements is a plus.
• Project management experience preferred. |
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| Contact Info |
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