Sr Specialist Regulatory Affairs
Sr Specialist Regulatory Affairs
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Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere 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 andResponsibilities.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.
- Bachelors 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.
Crossregion 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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
Senior IC
Employment Type
Full-Time
