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As the Associate Director, Regulatory Affairs you will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure alignment of the regional, clinical and Chemistry Manufacturing and Controls (CMC) regulatory strategies with the overall global strategy. In addition you will have responsibility for ensuring and assisting other GRLs in ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful planning and execution of the global regulatory strategy for assigned projects.
Other duties:
Required Qualifications:
Preferred Qualifications:
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