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You will provide regulatory support and advice for internal and external Customers in line with defined regulatory plans and in response to ad-hoc questions. The role will also...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
You will primarily work in therapeutic area specific/functional role as a leader and SME representing GRMW in matrixed stakeholder R&D program teams. This role provides a...
Formulate, lead and drive global CMC regulatory strategy for biosimilar projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the...
Provides global regulatory leadership of assigned program(s); Develops global regulatory strategies, including risk assessment and mitigation strategies; Participates in strategic...