Sr Specialist, Regulatory Affairs

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Responsible for Regulatory Intelligence Surveillance & Systems operations, including monitoring the regulatory landscape, development and maintenance of systems/databases, and assessment of systems, trackers, and databases used in compiling regulatory intelligence information, as well as ensuring timely dissemination of items monitored in a global regulatory landscape that have impact to Baxter.

Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

• Conducts monitoring, identifies key requirements that are relevant to Baxter, maintains awareness of regulatory requirements, and compiles global regulatory information for timely communication and to drive action within Baxter for compliance and strategic efforts.
• Conducts research on specific topics using regulatory intelligence data sources. 
• Compile, update, and maintain regulatory intelligence records and databases with continuous improvement of systems.
• Maintains internal systems used to track, trend, and continuously monitor the status of Baxter actions on intelligence, compliance, and advocacy targets. 
• Participate as an active team member and provide regulatory advice to project teams as required.
• Support regulatory intelligence activities relating to specific portfolio of products/projects, such as delivering periodic intelligence reports, program updates, presentations, newsletters, and other updates as assigned.

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

• Bachelor’s degree or country equivalent in a scientific discipline
• Minimum of 2 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization.

Cross-region experience preferred.  Drug, biologics and/or medical device experience preferred.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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