REGULATORY AFFAIRS Philadelphia, PA Preparation, review and submission of various Controlled Documents to the Food and Drug Administration (FDA). The approval by the FDA of the submissions will allow the company to market new products. ESSENTIAL DUTIES AND RESPONSIBILITIES 1. Preparation of Abbreviated New Drug Applications ANDAs and NDA’s for review by company management and submission to the FDA. 2. Preparation of Supplemental ANDAs and NDA’s for review by company management and submission to the FDA. 3. Preparation of Amendments to pending Applications and/or Supplemental Applications for review by company management and submission to the FDA. 4. Preparation of Annual Reports to ANDAs/NDA’for review by company management and submission to the FDA. 5. Preparation of Adverse Drug Events Reports for review by company management and submission to the FDA. 6. Preparation and/or review of documents for inclusion within the above referenced submissions. 7. Preparation of submissions for FDAs National Drug Code (NDC) Listing. 8. Assist the Manager, Regulatory Affairs in the preparation and submission of documents to various State Formularies. Assist the Manager, Regulatory Affairs to formulate submission strategies. Preparation of DMF’s as needed. Assist in the preparation with foreign (Europe) dossiers registration. Send resume to: emily@ajuliaexecutivesearch
Posted on: Mon, 28 Apr 2014 13:41:21 +0000
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