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Senior Global Regulatory Affairs Manager
Il y a 3 mois
Vantive: A New Company Built On Our Legacy
Baxter is on a transformative journey to establish our ~$5B Kidney Care segment as an independent entity. Vantive* will leverage our nearly 70-year heritage in acute therapies and dialysis, both at home and in clinical settings, to deliver exceptional care to our patients. We are confident that Vantive will not only enhance our leadership in the kidney care sector but also provide meaningful opportunities for those who join our mission.
At Vantive, you will be part of a dedicated community of professionals who are focused, courageous, and committed to excellence. We are driven to improve the lives of patients globally. Join us as we innovate kidney care and support other vital organ therapies.
*The proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) is subject to customary conditions.
Position Overview
This role presents an excellent opportunity to define global regulatory strategies and submissions for new and existing marketing authorizations within a global business unit, with a specific emphasis on electromechanical devices.
You will lead a functional team focused on electromechanical devices.
This position can be based in Meyzieu, France, with the option for remote work two days a week.
Key Responsibilities
Provide strategic and technical insights for regulatory decisions that align with business objectives. Identify and prioritize critical risk areas and ensure the implementation of effective mitigation strategies. Monitor, assess, and interpret all relevant regulatory requirements, ensuring compliance with Baxter and external standards. Evaluate the impact of new regulations and provide constructive feedback. Analyze technical and scientific data, identify gaps, and develop strategies to address potential risks. Serve as the primary liaison for meetings with regulatory authorities, including planning and leadership responsibilities. Foster effective communication within the Regulatory Affairs function, with GBU Marketing, and across project teams. Plan and manage complex projects while prioritizing workload effectively. Initiate and oversee operational activities to support new and existing marketing authorizations. Potentially manage the regulatory budget at the project level. Represent Baxter's interests in industry forums and working groups. Establish team or service objectives to ensure alignment with regulatory strategies. May provide direct supervision, including mentoring and performance management.Qualifications
Bachelor’s or Master’s degree (or equivalent) in a scientific discipline; a PhD is advantageous. Over 7 years of experience in Regulatory Affairs, including project or team management. Extensive regulatory knowledge related to electromechanical devices. Strong foundation in scientific training and communication. Proven ability to manage multiple projects within a matrix team environment. Experience working effectively in a multinational and multicultural setting. Interest in Regulatory Intelligence and experience in managing compliance and regulatory updates. Exceptional oral and written communication and presentation skills. Strong interpersonal and collaboration skills, with the ability to navigate conflicting priorities diplomatically. Capacity to lead, coach, and inspire others to achieve results. Proficiency in English is required.