Job Description

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally! Together we will shape the future of Sandoz are you ready to make a difference Position Purpose: Prepares and implements regulatory maintenance activities and second wave submissions to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches. Ensures that preparation of variations follow established processes and timelines. Acts as strong business partner and project team member for maintenance/compliance matters. Builds strong interface between the local functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements. Your Key Responsibilities: Your responsibilities include, but not limited to: Preparation of regulatory maintenance submissions, variations, renewals and second wave submissions, Modules 2 to 5. Effectively manages submission preparation to ensure implementation dates of variations and file availability dates of second wave submissions are met. Evaluates proposed changes and provides regulatory input for worldwide regulatory impact. Contributes to performance and KPI s of the team to deliver agreed targets and objectives and supports reporting. Provides DRCs/MRC sites/BD Regulatory, manufacturing business units with proper data and change evaluations to plan and implement registration activities and to meet commitments and requests of deficiency letters. Ensures that the escalation process to next or higher-level management is followed, as applicable. Handles deficiency responses and rejections. Ensures the receipt of proper product transfers from DRCs and BD Regulatory. Provides regulatory consultancy for products and STO. Ensures proper data management. ibution of marketing samples (where applicable) Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Minimum Requirements What you\'ll bring to the role: Essential Requirements: Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters and or Ph.D. At least 8 years of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred. Advanced project management skills Well-structured, result-oriented, highly self-committed, resilient, flexible, team player Ability to provide strategic guidance to the stakeholders. Why Sandoz Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! Division SANDOZ Business Unit Sandoz Global Development Country India Work Location Hyderabad, AP Company/Legal Entity Sdz Pvt Ind Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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