1996! In this year Sandoz initiated the world's first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. We are looking for curious, innovative, driven people to contribute to Sandoz success story in biosimilar development and help us get new biosimilar products into the market to improve access for patients. Maybe that's you.
Your responsibilities include, but not limited to:
* You have an important role in evaluating regulatory requirements and providing regulatory strategies when preparing or managing the timely delivery of high quality documentation required for worldwide Health Authority meetings, clinical trials, initial marketing authorization applications and dossier reviews * You know how to handle regulatory risks: you proactively identify and highlight potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations * You provide input and collaborate with relevant stakeholders when you focus on implementing strategies, ensuring timelines and formal requirements, or assuring congruency and compliance * You are an active member of the regulatory project (sub)team and where applicable, may act as representative of regulatory functions in the global project team(s) * You lead the preparation of responses to regulatory relevant queries from various stakeholders and you directly interact with regulatory authorities and/or with regulatory functions in the countries
