Dear Job Seekers,
DXC Technology India Private Limited is Hiring for:
Job Title: Regulatory Publishing
- 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