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Job Requirements of Regulatory Affairs Manager II:
-
Employment Type:
Contractor
-
Location:
Remote, OR (Onsite)
Do you meet the requirements for this job?
Regulatory Affairs Manager II
Careers Integrated Resources Inc
Remote, OR (Onsite)
Contractor
100% Remote (EST time zone)
12 months with possible extension
Performs eCTD submission management across ***'s product portfolio to Health Authorities for global development and lifecycle management submissions
The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products
Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle
The Regulatory Ops
Manager ensures submission deliverables are incorporated and visible to all stakeholders
Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality
Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.
Responsible for electronic submissions and documents meeting regulatory agency and *** submission standards and technical requirements
Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines
Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
Competent in the use of electronic document management and submissions publishing tools.
3-5 years of experience in regulatory operations providing submission delivery support for the US and Eurpoe.
Expereince overseeing publishing vendors preferred.
12 months with possible extension
Performs eCTD submission management across ***'s product portfolio to Health Authorities for global development and lifecycle management submissions
The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products
Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle
The Regulatory Ops
Manager ensures submission deliverables are incorporated and visible to all stakeholders
Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality
Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.
Responsible for electronic submissions and documents meeting regulatory agency and *** submission standards and technical requirements
Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines
Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
Competent in the use of electronic document management and submissions publishing tools.
3-5 years of experience in regulatory operations providing submission delivery support for the US and Eurpoe.
Expereince overseeing publishing vendors preferred.
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