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Total 51 jobs Found, displaying 10 results.
 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 11:15 AM
Job Responsibilities: · Authorship and review/approval level involvement on documents, such as Validation Planning, Requirements, Test Plans, System Testing, Validation Reporting and Release for Use. · Participate in the development, implementation, execution, and adherence to validation procedures and methods related to computer systems validation (CSV) · Provide validation support by giving inputs for defining validation strategy, development of validation deliverables and author validation documents per BMS project methodology in acco... 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 10:09 AM
Job Responsibilities: · In-depth Knowledge on Cisco Meraki devices and Cisco Routers and Switches. · Experience in working with Cisco Nexus switches with VPC, VSS and multi chasing ether channel. · In-depth understanding on MPLS circuits and DMVPN. · Thorough understanding of networking technologies, including advanced administration of enterprise routers, switches, and firewalls. · In-depth knowledge of network security methodologies as a whole, including but not limited to ACLs, next-gen, deep packet inspection f... 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
 Job Location : Princeton
 Job Type : Full Time
 Job Creation Date : 12/03/19 9:36 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 51 jobs Found, displaying 10 results.