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Regulatory Publishing


Last Updated: 7/26/21

Job Description

Dear Job Seekers,

DXC Technology India Private Limited is Hiring for:

Job Title: Regulatory Publishing

Job Description:

  • 7+ years of Regulatory Publishing
  • Managing & motivating the team towards a common goal and keep them focused
  • Ensuring that service levels are met and strive to exceed service levels Planning and managing training and ensure staff are adequately trained
  • Perform submission publishing, assembly and distribution activities.
  • Performing submission readiness checks. Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
  • Performing final technical quality review and technical validation (eCTD)
  • Notifying relevant stakeholders that the file is ready for approval Compiling SAS and other datasets and non-PDF files.
  • Dispatching submission to the relevant authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority; Knowledge of FDA / ICH guidelines, Life Sciences & Pharmaceutical industry Knowledge of health authority procedures/guidance regarding electronic submissions
  • Performing post-submission processing activities such as receiving acknowledgment from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders
  • Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
  • Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence
  • Ensuring ongoing coaching of team members and ensure personal development plans are in place for all team members By continually up-grading domain knowledge

Experience: 7+ years

Salary: As per the Company Standards

Location: Hyderabad

Company Details

Hyderabad, Telangana, India
JobSaplings India is a young recruitment-consulting firm known for providing timely, cost effective recruitment solutions with a low attrition rate. We have developed skills in spotting talents through head hunting and talent search mechanism for positions at all levels and functions. In the present era of hyper competition, human resources are crucial in maintaining one’s competitive advant...