Responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products. Serves as a consultant to managers. Compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Prepare, review, and approve labeling and SOP’s. Assist lower level team members on complex issues. Provide regulatory advice to project teams. Provide guidance and coaching for areas of responsibility to lower level team members. Respond to regulatory authorities questions with strict deadlines. Maintain regulatory files in a format consistent with requirements. Develop and initiate complex regulatory project plans. Manage regulatory activities relating to specific portfolio of products/projects (product owner). Maintain and update existing regulatory authorizations. Lead or represent Regulatory Affairs in project teams. May review promotional material for compliance with local regulations. Requires Bachelor’s degree or country equivalent in pharmacy or related scientific discipline. Masters and/or PhD will be an advantage. 5+ years or more of experience in RA or related field (preferably medical device, pharmaceutical, CRO, or similar), including people management or projects. Ability to oversee multiple projects in a matrix team environment. Excellent oral and written communication and presentation skills. Applicants must be authorized to work for any employer in the U.S. Baxter offers comprehensive compensation and benefits packages including medical, dental, insurance, retirement plans, paid time off, and other employee benefits.
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