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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BD,Quality (QA-QC) |
| EmploymentType | Full-time |
1886! We have more than 130 years of experience treating patients.Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.Your Responsibilities:Your responsibilities include but not are limited to: Preparation and maintenance of CDS/RSI and core English SmPCs/PILs/labels for new submissions, variations and renewals. Signal Detection & Evaluation: perform external signal detection by monitoring HA websites and/or the reference product label and enter identified signals into the CDS & SD database. Evaluation of signals from various sources and their impact on patient safety, and decide on actions to update labels. Organization of translations, if needed and readability testing of package leaflets Maintenance of core SmPCs/PILs/labels based on CMC or administrative changes Liaise with Managers to define submission strategy for EU. Ensure in-time hand-over of variation package or response documents to submission teams Maintain internal databases, documentation and other administrative actions as required Support country organizations, compliance/performance reporting and oversight. Support labelling projects, audit and inspections, and other specific tasks as assigned.Minimum requirements What You ll bring to the role: Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) Project management skills Well-structured, result-oriented, highly self-committed, resilient, flexible, team player Ability to communication and provide required inputs to stakeholders Experience in managing databases; maintaining SharePoint; with added skills in Excel, is preferred 1 year of relevant experience in the domain of regulatory with an exposure of working in a global organization in generics is preferred. Fresh campus graduates with high learning agility can be considered. Excellent communication skills in English requiredWhy consider Sandoz Our 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 world The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.Imagine what you could do at Sandoz!Commitment to Diversity & Inclusion:Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.,
Keyskills :
patient safetyproject managementcommunication skillssignal detectioncdsexcelertmsaccesstestingbiologystrategyleafletsreportingdatabasescmc