Associate Director, Global Regulatory Affairs Marketed Products - Boston
5 days ago
At Takeda we are a forward-looking world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide As an Associate Director Global Regulatory Affairs Marketed Products you will lead/contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex projects Provide strategic tactical advice to teams to achieve timely and efficient development and maintenance of programs while ensuring compliance with applicable regulatory requirements Are a leader within the department and within R&D contributing to department cross functional Takeda initiatives influencing the field as applicable Provide leadership/contributes as global regulatory lead GRL responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts
Responsibilities:
- The Associate Director will be responsible for increasingly complex or multiple projects Leads the Global Regulatory Team GRT represents GRT at project team meetings as global/regional regulatory lead Defines strategies provides tactical guidance collaborates cross-functionally ensures updates execution in line with changing needs Exercises sound judgement communicates professionally timely manner Proactively anticipates risks develops solutions scenario planning identified risks discusses team management understands probabilities technical success proposed solutions Accountable execution strategy including provision submissions local affiliates working regional leads functions vendors US FDA approvals project(s)
Job description
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