Manager Regulatory Affairs
- Job ID:
- Date:12/30/2008
- Location:Greensboro
- State:North Carolina
- Salary:Not Specified Why?
- Job Types:
-
Pharmaceutical Regulatory Affairs
Job Description
Purpose:
To initiate and manage regulatory affairs and pre-marketed drugs, devices, and biologics.
Essential Duties:
-Supervise and manage pre-marketing activities in the regulatory department.
-Oversee pre-marketing regulatory activities for global projects including: preparation of FDA Briefing Documents and INDs and independent research to determine strategy.
-Strategize and communicate with FDA for IND/IDE/BLA as well as NDA/BLA/PMA applications.
This description is not intended, and should not be construed, to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with this job. It is intended to be an accurate reflection of the principal job elements essential for making compensation decisions.
Minimum Requirements:
- Bachelor's degree in scientific or health discipline.
- Minimum of 5 years experience in pre-marketing Regulatory Affairs in pharmaceuticals or biotechnology required.
-Must be proficient in Microsoft Office. Experience with Microsoft Project helpful.
-Broad knowledge of Regulatory Affairs.
-Previous hands-on experience with submissions is required. Must have thorough understanding of the FDA process.
-Experience in FDA communications and ANDAs is preferred.
-Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail including strong proofreading skills required.
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