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, passionate 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 Job Purpose: 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 interface between the local functions (STO/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: . Preparation of regulatory life cycle maintenance submissions - variations, renewals and second wave submissions, Modules 2 to 5 as per defined timelines. . Evaluates proposed changes and provides on time regulatory input for worldwide regulatory impact. . Contributes to performance and KPI\'s of the team to deliver agreed targets and objectives and supports reporting. . On time response to HA commitments, and deficiency letters. . Ensures that the escalation process to next or higher-level management is followed, as applicable. . Supports in case of rejections investigation. . Ensures the receipt of proper product transfers from DRCs, MRCs and BD Regulatory. Provides regulatory consultancy as and when requested by STO/ESO. . Ensures proper data management and completion of all assigned trainings within specified timelines. Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Minimum Requirements Education Requirements : Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors Languages : Good written and spoken English. Local language is an advantage Experience/Professional : Requirements At least 5 - 7 years of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred. Exposure towards project management is a plus. Well-structured, result-oriented, highly self-committed, resilient, flexible, team player. High operational excellence orientation

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