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 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
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
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
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