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 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
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
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
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
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
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
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
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
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