Taking ownership of deliveries that were translated internally or by external partners for one or more accounts... events) Regulatory affairs expert (managing submissions to health authorities like the FDA or EMA) Or similar scientific...
, ensuring systems are compliant with FDA, EMA, MHRA, and other applicable regulatory requirements. Key Responsibilities: Plan... transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design...
with key partners, leading a supply chain sub team with cross-functional stakeholders for end to end alignment The Global... to current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA...
with internal / external partners such as CTOs, CDMOs and Takeda’s R&D and commercial organizations across global and cross cultural... environments. Understand and implement regulatory knowledge such as FDA, EMA, PMDA and ICH guidelines for analytical development...
external network. The role partners closely across Cell Therapy Development and Operations to ensure setup, maintenance... is the manufacturing relationship owner for the alliance partners for assets in scope and is highly matrixed. Assets in scope...
(local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required Extensive knowledge in a broad range... with the business partners such as CMO, analytical labs and so on. Ability to work globally in a matrix environment Ability...