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Total 47 jobs Found, displaying 10 results.
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 01/20/20 3:49 PM
Job Duties:· Participate on computerized system validation and implementation project teams.  · Author computer system validation documentation ensuring compliance with applicable FDA Regulations that is 21CFRPart11 and 21CFRPart820. · Follow GAMP5 practices for authoring and reviewing Validation Documentation. · Implement formal testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval and delivery. ... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/24/19 9:27 AM
Job Responsibilities: · Create and maintain technical writing standards for the Automation and Engineering unit. · Write and create automation periodic evaluation reports for automated systems used in commercial pharma manufacturing, analytical testing and training/document tracking/retention. · Perform and document investigations and risk assessments of pharmaceutical complex related deviations and anomalies. · Write and oversee specific validation review/approvals for modifications/change controls/revision histories to d... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/13/19 10:26 AM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/12/19 10:11 AM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/11/19 7:40 AM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/10/19 1:06 PM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/09/19 1:00 PM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/06/19 12:56 PM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/05/19 9:03 AM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/04/19 10:09 AM
Regulatory Affairs Assoc:   Prepare FDA regulatory compliance submissions and annual reports. Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.   Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA. Provide labeling documentation [draft or final printed labeling (SPL)] in response to deficiency letters within specified time frames based on corporate priorities. Participate in team decision-making concerning regulatory compliance and polici... read more
Total 47 jobs Found, displaying 10 results.