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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Your responsibilities include, but are not limited to: Lead and manage the Regulatory Information Management & Systems Technical Services team. Responsible to support an efficient and globally harmonized service model and ensure timely, high quality and compliance deliverables according to given timelines. The service model includes but is not limited to submission resource planning, submission publishing, document processing and data entry. Take leadership and ensure that the Regulatory submission publishing, document processing and data entry function deliverables are provided in high quality, in compliance with Health Authority requirements and according to given timelines. Act as the main contact during the submission preparation and execution phase of product development and initial submission projects. Receive and resolve or mitigate is- sues. Implement actions to prevent that issues happen again Act as a service provider for customers in Regulatory and stakeholders outside of Regula- tory. Build up a communication network with the stakeholder community Inform IM&S LT about the progress of ongoing activities and provide performance re- ports on a regular basis Ensure timely updates of submission data in the Regulatory Information Management databases and verify that the data is kept compliant Ensure timely and efficient processing of regulatory, submission- relevant documents like M1, eApplication Form, COPPs, GMP Certificates Collaborate closely with the RA IM&S leadership team to facilitate a highly performing IM&S organization which supports global Regulatory Affairs with the optimum efficiency. Why consider SandozOur number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA- cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever- more digital and global worldThe answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. Sandoz, a Novartis,
Keyskills :
dataentryresourceplanningtechnicalservicesproductdevelopmentdocumentprocessinggmptatementsofwksowmusicmakingregulatyaffairsmanagementsystemsdigitalconversioninfmationmanagement