Compliance

• manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
• leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
• develops regulatory strategy and provides regulatory input as appropriate
• ensures compliance with global regulatory requirements and coordination of regulatory compliance activities at a global level
• provides updates to the Global Regulatory Team, project teams, and governance boards as needed
• maintains professional working relationships with colleagues, fostering collaboration, and idea sharing
• reviews nonclinical, clinical and CMC documentation and contributes to content as needed

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Director, Regulatory Reporting

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