Regulatory Operations, Submission Management

SGS_JOB_1037

Scientific
Remote
eCTD Submission Management
Publishing
QC checks
Health Authority Guidelines/Regulations

Contract - 08 Months+

Performs eCTD submission management across Biogen's product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Ops. 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.

Job Responsibilities:

  • Acts as the primary point of contact for regulatory functions as appropriate in the product’s lifecycle.
  • The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.
  • Ensure 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 Biogen submission standards and technical requirements.
  • Quality 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

Skills:

  • eCTD Submission Management
  • Publishing
  • QC checks
  • Health Authority Guidelines/Regulations

Education/Experience:

  • Minimum Education qualification required. :  Bachelor's
  • Years of experience required: 5 plus years of experience

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