Sr Specialist - Regulatory Affairs

This is where your work makes a difference. 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 efficient 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.  Your Role at Baxter: This role is responsible for providing regulatory support for on-market products.  Activities include change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams. What you'll be doing: Review and provide regulatory impact assessments for changes Support global submission deliverables for product variation submissions Responsible for working with other parts of the regulatory organization to achieve desired results. Execute global plans and regulatory submission deliverables for sustaining variations Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results Ensure identified standards and content requirements are met for regulatory submissions Timely, actively support query responses Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s). Maintain regulatory files in a format consistent with requirements Tracking of status, quality/compliance and progress of regulatory documentation Review, edit and proofread regulatory documentation What you'll bring:  Master's Degree or country equivalent in related scientific discipline Higher degree/PhD will be an advantage, 7+ years’ regulatory experience in RA or related healthcare environment Experience in Regulatory Information Management (RIM) systems, including managing regulatory data, submissions, registrations, and maintaining data quality and compliance. Experience in CMC regulatory authoring, including preparation and review of CTD Module 3 documentation and supporting global regulatory submissions throughout the product lifecycle. Experience operating in a regulated environment Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines Exercise independent judgement