Shraddha Yewale
Regulatory Operations Publishing at SandozI Ex Freyr I Ex TCS IGCOPK #eCTDsubmissionpublishing #regulatorysubmissionmanagement
- Role
- Rops Publishing Associate at Sandoz
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
Experience
Rops Publishing Associate
Jan 2025 — Present · Hyderabad, IN
Responsible for preparation and dispatching the Cover letter, Application form as per country specific requirements for Work-sharing and Super grouping for EU NAT procedures.• Responsible of importing the local documents in SARA system, submission publishing and validating the application sequence using SELECT DB tool.• Troubleshooting the issue in eCTD high level of errors and warning.• Creating the delivery file using CESP portal and uploading the submission repository and packages in SELECT DB to Health Authority.• Submitting the UK submissions to MHRA portal and archiving the notification emails• Assessing and resolving the issue received from the country officer.• Updating and tracking submitted planned submission to Health Authority in Veeva vault system.• Timely co-ordinating and submitting the work-sharing and super grouping submissions to Health Authority.• Actively managing the high-capacity workload and submitting the submissions to Health Authority.• Participate in submissions team meetings and submission managing activities in team.
Education
Government College Of Pharmacy, Karad
Bachelor of Pharmacy - BPharm
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