Job title: Senior specialist regulatory affairs

Qualifications:

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.

Job profile:

• 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.