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 effective 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
This role is responsible for providing regulatory support for on-market products. Activities include change assessment, variation planning and submission, creation of submission documentation, identification of local submission requirements, product/facility change management, process support,
and participation in project sub-teams.
Essential Duties and Responsibilities
- Review and provide regulatory impact assessments for changes
- Support global submission deliverables for product variation submissions in Europe, USA, and RoW countries.
- 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 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 proje
📌 Sr Specialist, Regulatory Affairs (Bengaluru)
🏢 BAXTER
📍 Bengaluru
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