Associate Director, Regulatory Affairs - Device Job in New Jersey (NJ), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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Associate Director, Regulatory Affairs - Device job in Princeton

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Novartis Pharmaceuticals jobs
New Jersey (NJ), Princeton
Job Code:  240445BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  New Jersey (NJ)
City:  Princeton
Map: 
09/05/2018

Description
The Associate Director, Regulatory Affairs will be responsible for PDMA compliance and regulatory approval of all digital therapeutic product line marketing and professional material, selling documents and promotional materials through PRC. Must have working knowledge of Device regulations [510(k), IDE and PMA]. The incumbent will also be responsible for interpreting pre-clinical/clinical trials, data collection, pharmacology, toxicology, drug metabolism, and clinical research in support of 505(b)(2) applications. Facilitate and support the due diligence and co-development of compounds through the various stages of clinical research; collaborate with all disciplines within the Company. Help prepare quality documents for submission to regulatory agencies to permit the legal distribution of pharmaceuticals for clinical or commercial purposes.BA/BS/MS/Ph.D. in Biological or Pharm Sci-ence. Required BA/BS, Preferred MS/PhD. • Fluent in English required 7-10 years regulatory or related experience in the pharmaceutical industry. Excellent written and verbal communication skills. Knowledge of regulatory requirements, guidance's and regulations (US) within the pharmaceutical industry, specific to the areas of clinical research, product development and labeling.
ref: (240445BR)
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