At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for productive and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Summary:
Under limited supervision responsible for the implementation of global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products.
Support regulatory activities relating to specific portfolio of global products/projects.
Essential Duties and Responsibilities:
- With direction, develop and execute regulatory project plans
- Identify and elevate key areas of regulatory risk
- Maintain regulatory files in a format consistent with requirements
- Maintain awareness of regulatory requirements; identify relevant requirements
- Participate as an active team member and provide regulatory advice to project teams as required
- Respond to questions from regulatory authorities within strict timelines
- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
- Maintain and update existing regulatory authorizations
- Support regulatory activities relating to specific portfolio of products/projects
- Prepare, review, and approve labeling and SOP’s
- Represent or lead Regulatory Affairs in small project teams