Biosimilars Regulatory Affairs Senior Manager

As the Biosimilars Regulatory Affairs Manager you will be responsible for defining and aligning all regulatory activities related to biosimilars for development, initial MAA/BLA registrations, and post-approval life cycle management at Zentiva. You will lead the development and execution of global regulatory strategies in close collaboration with co-development partners and internal and external stakeholders. Acting as regulatory lead for complex projects, you will draw upon broad regulatory and technical expertise to provide well-informed guidance across the organization. You will contribute to cross-functional planning and decision-making, ensuring alignment with global regulatory expectations and driving the successful delivery of Zentiva’s biosimilar strategy.…