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 and second wave submissions follow established processes and timelines. 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. . Ensures the receipt of proper product transfers from DRCs, MRCs and BD Regulatory. . Ensures proper data management and completion of all assigned trainings within specified timelines. . Any other responsibility assigned after training (as applicable). 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 -Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Bachelors -Good written and spoken English. Local language is an advantage. -At least 2-4 years of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred. Fresh campus graduates with high learning agility can be considered. -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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