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| Job Location | Hyderabad |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Medical / Healthcare |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
257106BRSenior Specialist - IM&SJob DescriptionPosition Purpose Ensure preparation, validation, dispatch and submission of compliant and high quality initial, 2nd wave and maintenance Regulatory filings according to submission plans. Update respective Regulatory systems for Registration Management, Publishing and Document Management. Support the Global Regulatory teams during the product development phase and provide input as appropriate Follow Regulatory procedures and timelinesMajor Accountabilities Support regulatory teams during the submission process in all administrative and technical steps according to global procedures Prepare and dispatch/submit documentation packages for initial submissions, 2nd wave submissions, variations, renewals, PSUR and other submission types in compliance with Health Authority requirements in European and National Procedure Ensure eCTD lifecycle maintenance according to ICH and regional specifications Ensure timely update 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 Maintain communication network with regulatory functions including country organizations, non-regulatory stakeholders and health authorities and reply to customer requests Coordinate and process eCTD submissions for local license products with the country organizations Ensure escalation procedures are followed in case of issues and delays Support reporting Contribute to projects driven by Business Process Excellence or IT System & StrategyKey Performance Indicator 1. KPIs like on-time filing dispatch/submission, submission rejection rate, customer satisfaction (e.g. regulatory competence, responsiveness) 2. All assigned project deliverables meet targets for quality, productivity in compliance with Regulatory and /or health authorities requirements 3. Delays in launches and supply caused by GRA (None) 4. Regulatory complianceMinimum requirementsUniversity or College Degree in any field or life science with relevant industry experience or comparable degree Good communication in English (oral and written) At a minimum 5 years experience in the Pharmaceutical area, specifically in Regulatory Operations Proven experience in the Regulatory submission publishing, area. Knowledge of Regulatory guidelines for the areas mentioned above Organizational awareness, including significant experience working cross-functionally and in global teams. Ability to work independently, under pressure, demonstrating initiative and flexibility High level understanding of Regulatory quality, standards and policies. Attention to detail and quality focused Team-mindedDivisionSANDOZ Business UnitProduct Dev SZ CountryIndia Work LocationHyderabad, AP Company/Legal EntityNov Hltcr Shared Services IndFunctional AreaResearch & Development Job TypeFull TimeEmployment TypeRegular ,
Keyskills :
troubleshootingroductdevelopmentprocessexcellenceregulatoryfilingsdigitalconversionactivedirectorysharedservicesqualitystandardsbusinessprocess