Senior Specialist, Regulatory Affairs at Baxter International in Bangalore

Job description

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 affairs support for on-market products. Key responsibilities include assessing product and manufacturing changes, planning regulatory variations, preparing and compiling submission documentation, identifying country-specific regulatory requirements, supporting product and facility change management activities, providing regulatory process support, and participating in cross-functional project teams. What you'll be doing Review product, manufacturing, and facility changes and provide regulatory impact assessments. Support global regulatory submission deliverables for product variation submissions. Collaborate with stakeholders across the regulatory organization to achieve project objectives and regulatory outcomes. Execute global regulatory plans and submission deliverables for sustaining product variations. Apply regulatory knowledge and expertise to prepare high-quality submission deliverables that support successful regulatory outcomes. Ensure that applicable regulatory standards, guidelines, and content requirements are met for all regulatory submissions. Provide timely and proactive support in preparing and coordinating responses to regulatory authority queries. Engage with Global Business Unit Regulatory teams and Regional Regulatory Affairs teams to ensure regulatory activities are aligned with business objectives and requirements. Partner with regulatory affairs sub-functions to provide seamless regulatory support to cross-functional project teams. Maintain regulatory files and documentation in compliance with applicable regulatory and company requirements. Track the status, quality, compliance, and progress of regulatory documentation and submission activities. Review, edit, and proofread regulatory documents to ensure accuracy, consistency, and compliance with regulatory requirements. What you'll bring Master's Degree or equivalent qualification in a related scientific discipline. A higher degree, such as a Doctor of Philosophy (PhD), is an advantage, along with 7+ years of regulatory affairs experience in Regulatory Affairs (RA) or a related healthcare environment. Experience with Regulatory Information Management (RIM) systems, including managing regulatory data, submissions, registrations, and maintaining data quality and compliance. Experience in Chemistry, Manufacturing, and Controls (CMC) regulatory authoring, including the preparation and review of Common Technical Document (CTD) Module 3 documentation and support of global regulatory submissions throughout the product lifecycle. Experience working in a regulated healthcare, pharmaceutical, biotechnology, or medical device environment. Ability to operate effectively in a matrixed environment and manage multiple priorities, activities, and deadlines simultaneously. Demonstrated ability to exercise independent judgment and make informed decisions. Strong scientific knowledge, with the ability to discuss complex technical matters effectively with cross-functional stakeholders. Solid understanding of global regulatory requirements and the ability to interpret, communicate, and apply regulations effectively. Ability to identify compliance